FDA approves Medtronic’s slimmer Valiant Navion thoracic stent graft

Medtronic received FDA approval for its Valiant Navion thoracic stent graft for minimally invasive repair of all lesions of the descending thoracic aorta, a slimmer iteration that the company says allows for more patients to undergo a percutaneous procedure instead of open surgery.

Boston Scientific’s surgical arm helps fuel 52% jump in third-quarter net income compared to 2017

Boston Scientific saw $2.393 billion in third-quarter sales this year—resulting in a net income of $432 million, or a 52.7% increase compared to the $283 million haul from the same time period in 2017.

Roche’s single-dose flu drug Xofluza, Tamiflu’s successor, wins speedy FDA approval

Xofluza, also known as baloxavir marboxil, is now “the first new antiviral flu treatment with a novel mechanism of action approved by the FDA in nearly 20 years,” FDA Commissioner Scott Gottlieb, M.D., said in a statement. For Roche’s Genentech, which gained ex-Japan/Taiwan rights from developer Shionogi in 2016, Xofluza is tasked with salvaging some big sales that generics to its popular flu drug Tamiflu have eaten up.

Donald Trump’s Orange Complexion Due To Chloraprep From Last Plastic Surgery

Washington D.C– The U.S. Surgeon General accidentally revealed in a recent interview that President Trump’s skin tone is actually a normal shade of Caucasian. The orange hue of his face is actually due to daily Chloraprep application after a brow lift he had performed early in the 2016 Republican Presidential Primary.chloraprepThe newly appointed Surgeon General Dr. Adams was being interviewed about a public health initiative when he revealed that one of his daily responsibilities is to apply a fresh coat of the orange tinted chlorhexadine usually reserved for pre-operative surgical prep. “He loved the way his face shined after surgery and asked if he could look like that all the time. When I told him it was an antimicrobial skin prep, he said he never liked microbial skin preps anyways.”Dr. Adams relayed that the president’s staff carries a case of Chloraprep applicators every where they travel with the President. “We’ve used an average of 2.6 applicators a day, way more than that when he is going to be on TV. He believes that the population relates to it, President Trump believes that this specific shade of orange reminds people of Cheetos, Doritos and Tang. The flavors of a happy childhood he claims.”

Source : http://gomerblog.com/2017/09/donald-trumps-orange-complexion-due-to-chloraprep-from-last-plastic-surgery/

 

Washington D.C– The U.S. Surgeon General accidentally revealed in a recent interview that President Trump’s skin tone is actually a normal shade of Caucasian. The orange hue of his face is actually due to daily Chloraprep application after a brow lift he had performed early in the 2016 Republican Presidential Primary.chloraprepThe newly appointed Surgeon General Dr. Adams was being interviewed about a public health initiative when he revealed that one of his daily responsibilities is to apply a fresh coat of the orange tinted chlorhexadine usually reserved for pre-operative surgical prep. “He loved the way his face shined after surgery and asked if he could look like that all the time. When I told him it was an antimicrobial skin prep, he said he never liked microbial skin preps anyways.”Dr. Adams relayed that the president’s staff carries a case of Chloraprep applicators every where they travel with the President. “We’ve used an average of 2.6 applicators a day, way more than that when he is going to be on TV. He believes that the population relates to it, President Trump believes that this specific shade of orange reminds people of Cheetos, Doritos and Tang. The flavors of a happy childhood he claims.”

Source : http://gomerblog.com/2017/09/donald-trumps-orange-complexion-due-to-chloraprep-from-last-plastic-surgery/

Boston Scientific jumps on media report of takeover interest from Stryker

Boston Scientific shares jumped almost 10 per cent on Monday after a media report Stryker made an approach to purchase the rival maker of medical devices.News of a possible takeover come amid a flurry of dealmaking in the healthcare sector.The shares were recently up 8.3 per cent in mid-morning trade in New York. Monday’s report from The Wall Street Journal triggered a brief volatility halt, according to New York Stock Exchange data.The Journal cautioned in its report, which cited unnamed sources, that it is “unclear” whether Boston Scientific is receptive to the approach.Boston Scientific’s enterprise value, which includes net debt, was $48bn as of Friday, FactSet data show.The group, which makes devices such as medicated stents for cardiac patients, generated $9.05bn in net sales last year.

FDA approves Cook Medical’s Hemospray aerosol for stopping GI bleeds

The FDA granted premarket approval to Cook Medical’s Hemospray, an aerosol to help control most types of bleeding within the upper and lower gastrointestinal tract, including those caused by gastric ulcers, cancer, malformed blood vessels, diverticulosis or inflammatory bowel disease.

Stryker gets CE mark for 24-hour stroke device

Stryker has received European clearance to use its stroke device Trevo Retriever up to 24 hours after the onset of symptoms. The CE mark comes three months after the FDA signed off on the expanded indication.Gaining the back-to-back regulatory clearances positions Stryker to extend the treatment window for stroke patients. In the past, doctors only used Retriever and other thrombectomy devices to remove blood clots in the six hours after a patient suffered a stroke. Now, using Retriever, doctors can perform thrombectomies for up to 24 hours after symptom onset.

US$62 Billion worth of GCC Healthcare Projects planned or underway 

A total of US$62.1 Bn. worth of projects are either planned or underway in the GCC as of 25th March 2018, as per Ventures ONSITE. The number also includes projects on hold which is estimated to be around US$18.6 Bn. The value of projects in the construction stage adds up to US$30.8 Bn. while the value of projects in the pre-construction stage totals US$12.7 Bn.

Of the 6 GCC Countries, KSA, followed by UAE and Kuwait, are the major contributors of Healthcare projects.

Major Hospital Projects awarded to Contractors in the last 3 months

Al Moosa Specialist Hospital Expansion in Al Ahsa – North Tower-KSA

220 Beds Hospital In Jeddah-KSA

Knowledge Economic City in Madina (KEC) – Al Mouwasat Hospital-KSA

Saudi German Hospital Riyadh – Outpatient Tower-KSA

Sultan Qaboos Cancer Center in Muscat-Oman

NMC Speciality Hospital Expansion at Al Nahda 2-Dubai

Interesting Figures to Know

Value of Gemelli Hospital in Muscat announced by Elixir United Investment & Al Jazeera International Group in early 2018 is US$260 Mn.

Source : www.venturesonsite.com

Boston Sci to buy prostate device firm NxThera in $400M deal

Boston Scientific has struck a $406 million deal to buy NxThera and its treatment for benign prostatic hyperplasia (BPH). The takeover will bolster Boston Scientific’s urology business through the addition of a minimally invasive, radiofrequency-based way of destroying obstructive prostate tissue.

Cardiology World Erupts Into Controversy Over Change In Major Clinical Trial

As a major clinical trial in cardiology nears completion it has provoked a storm of criticism and controversy.The brouhaha erupted in response to a late change to one of the most important— and already controversial— trials in cardiovascular medicine. The NIH-funded ISCHEMIA trial was designed back in 2011 to provide a definitive answer to the important and complicated question of whether stents provide something more than symptomatic relief to patients who have stable angina (i.e., who are not having a heart attack or other acute coronary event). The change to the trial, say the trial critics, means that the long and expensive trial won’t be able to deliver a definitive resolution to this question.

India proposes caps on use of imported medical devices

India has proposed regulating the proportion of locally made and imported medical devices procured by public programs. The draft guidelines (PDF) called for at least 50% of some types of devices to come from Indian companies.Local companies gained preference over foreign businesses under Indian public procurement rules last year. But those general, pan-industry rules stopped short of stipulating how the “Make in India” promotional agenda would apply to the procurement of medical devices. A draft document released by the Department of Pharmaceuticals (DoP) has now filled that gap.The document stated that at least half of all medical disposables and consumables must come from local companies. The DoP took a somewhat looser line on the acquisition of medical electronics, hospital equipment, surgical instruments, implants, diagnostic reagents and IVDs. Public programs need to buy between 25% and 40% of these types of devices from local companies.

Johnson & Johnson receives $2.1B bid for LifeScan diabetes unit

Private equity group Platinum Equity has offered Johnson & Johnson $2.1 billion for LifeScan. J&J has until the middle of June to accept the offer for its blood glucose monitoring business. J&J signaled its interest in offloading LifeScan and two other diabetes device units—Animas and Calibra Medical—at the start of last year. Since then, Chinese investors have reportedly weighed up bids for the units. But Los Angeles-based Platinum Equity has now emerged as the front-runner to buy LifeScan and its portfolio of glucose monitoring products.

Legal cases against Bayer drive surge in Essure safety reports at FDA

The FDA has received a glut of safety reports related to Bayer’s birth control device Essure. Attorneys involved in legal cases against Bayer provided the information to the agency, which is now evaluating the reports.FDA Commissioner Scott Gottlieb, M.D. said the agency received 12,000 reports related to Essure last year. More than 90% of the reports covered issues related to potential device removal. But some of the reports lack information about whether the patient ultimately had the device removed. The FDA is working to better understand the drivers of device removal as part of its review of the reports.That means the FDA has a sizable job on its hands. Gottlieb thinks the agency will need to follow up on the reports to gather extra information regarding removal.

Reva gets CE mark for bioresorbable scaffold with thinner struts Than Absorb 

Reva Medical has secured (PDF) the CE marking of its bioresorbable scaffold. The European regulatory nod clears Reva to push a device it thinks addresses some shortcomings of other products in the nascent but faltering bioresorbable scaffold sector.Bioresorbable scaffolds were hailed as the next step in the innovation chain after bare metal stents and drug-eluting variants. But Abbott stopped sales of its bioresorbable scaffold last year in the face of low sales and safety concerns. Around the same time, Boston Scientific dealt the sector a blow by scrapping its bioresorbable stent program.Reva has pushed on as its larger rivals have dropped out of the race, but its first-generation scaffold is still finding its feet. Commercial sales of the device—Fantom—got underway last year. By the third quarter, Reva was shipping $105,000 worth of the scaffolds and booking $17,000 of revenue.The commercial push will now benefit from a revised version of the scaffold, Fantom Encore. The big difference between the two scaffolds is the thickness of the struts, which Reva has shrunken down to 95 microns. That is closer to the 83-micron struts of Abbott’s drug-eluting stent Xience than the 150-micron struts of the healthcare giant’s now-dropped bioresorbable scaffold.

J&J Could Explore Potential $2B Sale of Sterilization Products Division(ASP)

Life sciences giant Johnson & Johnson Family of Companies may be shopping around its sterilization products division. The asking price could be as high as $2 billion, according to reports.Citing unnamed people familiar with the matter Bloomberg reported J&J is actively working with an advisor to solicit bids for the business unit. The potential sale of the division is drawing interest from strategic buyers and private equity companies, according to the report. Bids for the division could come in by the end of this week, the sources told Bloomberg.

Stryker Receives FDA Clearance for Cementless Mako Total Knee with Triathlon® Tritanium®

Stryker’s Joint Replacement division today announced that its cementless Mako Total Knee with Triathlon Tritanium has received 510(k) market clearance by the U.S. Food and Drug Administration.Triathlon Tritanium combines the kinematics of Stryker’s market leading Triathlon knee implant with the latest in highly porous biologic fixation technology for a knee system like no other.  The innovation of Tritanium’s tibial baseplate and metal-backed patella components are enabled by Stryker’s proprietary AMagine additive manufacturing technology and are SOMA-designed. With cementless procedures rising in popularity and becoming a fast-growing trend1, Mako Total Knee with Triathlon Tritanium expands the current robotics offering to provide a cementless solution for orthopaedic surgeons seeking a more predictable surgical experience combined with increased operating room efficiency, biologic fixation and an alternative to bone cement.

NMC Health Buys Rest of Fakih IVF And As Salama Hospital

NMC Health said that it has acquired the outstanding minority stakes in Fakih IVF and As Salama Hospital for a total consideration of about US$218 million. The Company also announces the completion of the Al Qadhi and Al Rashid Hospital transactions in the Kingdom of Saudi Arabia.NMC noted that it has acquired the outstanding 49% minority stake in Fakih IVF at approximately the same Enterprise Value as the original acquisition cost set in 2015. The acquisition is being settled in the form of cash and newly issued shares in NMC Health with a total consideration of US$205 million (27% cash, 73% NMC shares issued, which represents 3.5 million shares or 1.8% of NMC’s current issued capital based on NMC’s current share price of £29.20). In addition, Dr. Michael Fakih will retain his role as a Medical Director in NMC and continue his practice as a medical doctor.The outstanding 30% minority stake in As Salama Hospital was acquired at the same Enterprise Value of USD 45mn which was set in 2016 with the initial 70% stake. The acquisition is being fully settled in cash.

Indian legislator seeks price caps for 20 medical devices

A member of India’s parliament asked Prime Minister Narendra Modi yesterday to cap the prices on 20 medical devices, in addition to the orthopedic and cardiac products that are already cost-limited there.The caps enacted by India’s National Pharmaceutical Pricing Authority on knee implants and cardiac stents have caused other major medtech players to seek to withdraw their devices from India. In April, the NPPA rejected applications from Medtronic and Abbott to pull their respective Resolute Onyx and Absorb stents (Abbott has since taken Absorb off the global market, citing lackluster sales). The NPPA is already considering further caps for other medical devices.

BD wins $50m Pentagon contract

Becton Dickinson & Co. subsidiary CareFusion won a U.S. Defense Dept. contract worth nearly $50 million, the Pentagon said yesterday.San Diego-based Carefusion Solutions won the five-year, $49.5 million contract for medical equipment. The firm-fixed-price with economic-price-adjustment deal was awarded after the military reviewed bids from 31 suitors and is good to Dec. 20, 2022.

Cleveland Clinic Abu Dhabi conducts UAE’s first full heart transplant

Physicians at Cleveland Clinic Abu Dhabi, part of Mubadala’s network of healthcare providers, have successfully conducted the UAE’s first full heart transplant.The surgery was performed by Dr Rakesh Suri, acting CEO of Cleveland Clinic Abu Dhabi, Dr Johannes Bonatti, chief of the Heart and Vascular Institute, Dr Stefan Sanger, clinical associate, and Dr Jehad Al Ramahi, clinical associate.Sheikh Abdullah bin Mohammed Al Hamed, chairman of the Health Authority, said in comments published by state news agency WAM: “What we have accomplished today is a historic accomplishment that adds to the long list of UAE achievements. It is a clear indication of the qualitative shift in Abu Dhabi’s healthcare under our wise leadership, who have invested the time and effort to provide the country’s population with such distinguished services.

US House proposes 5-year extension to medical device tax suspension

 

Boston Scientific wins FDA nod for Vercise DBS for treating Parkinson’s disease

Boston Scientific said yesterday it won FDA approval for its Vercise deep brain stimulation system designed to treat symptoms of Parkinson’s disease.The device, initially launched in Europe in 2012, was developed based on cochlear implant technology and is designed to stimulate a targeted region of the brain through implanted leads powered by an implantable pulse generator.  The device also has the ability to independently control the amount of current delivered on each lead, the company said.“This approval marks an important step for patients who will now have the choice to be treated with one of the most innovative neuromodulation technologies available today. Our system stands apart from the field in its approach and is changing the traditional definition on how we can leverage technology to treat patients with Parkinson’s disease,” neuromod prez Maulik Nanavaty said in a press release.

Catheter thrombolysis doesn’t lower risk of post-thrombotic syndrome, raises bleeding risk

study of catheter-guided thrombolysis in patients with deep-vein thrombosis found no reduction in risk for post-thrombotic syndrome but a higher risk of major bleeding.The study, published in the New England Journal of Medicine, examined 692 patients with acute proximal deep-vein thrombosis, randomized to receive either anticoagulation drugs alone or anticoagulation plus pharmaco-mechanical thrombolysis. The experimental arm was treated with the intra-thrombus delivery of recombinant tissue plasminogen activator and thrombus aspiration or maceration, with or without stenting. The primary outcome was development of PTS between 6 and 24 months.The researchers found no significant difference between the groups in terms of PTS, which was found in 47% of the experimental cohort and in 48% of the control group. But there were more major bleeding events in the interventional arm within 10 days (1.7% vs. 0.3%).However, there were no significant differences in recurrent venous thromboembolism over two yaers, with 12% occurring in the pharmaco-mechanical-thrombolysis group and 8% in the control group. Moderate-to-severe PTS occurred in 18% of patients in the treatment arm versus 24% in the control group.

Stryker to buy Entellus Medical for $662 M

Medical device maker Stryker Corp said on Thursday it would buy medical technology company Entellus Medical Inc in a deal valued at about $662 million, adding heft to its ENT business.Stryker would pay $24 per Entellus share, a premium of about 50 percent to Entellus’s Wednesday close.The deal to expected to be dilutive to Stryker’s 2018 adjusted net earnings per share by about 4 cents.

Merit Medical Signs Purchase Agreement with BD for Divestment Assets

Merit Medical Systems, a leading manufacturer and marketer of proprietary disposable devices used in interventional, diagnostic and therapeutic procedures, particularly in cardiology, radiology, oncology, critical care and endoscopy, announced today that it has signed an asset purchase agreement with BD (Becton, Dickinson and Company) to acquire certain assets which BD proposes to sell in connection with its proposed acquisition of C.R. Bard, Inc. (Bard).  Merit’s proposed asset acquisition is subject to the closing of BD’s proposed acquisition of Bard as well as other usual and customary closing conditions.The assets to be acquired are soft tissue core needle biopsy products currently sold by BD under the trade names of Achieve™ Programmable Automatic Biopsy System, Temno™ Biopsy System and Tru-Cut™ Biopsy Needles.  Merit understands these products are currently sold worldwide through a combination of a direct sales force and distribution partners.Additionally, Merit proposes to acquire the Aspira® Pleural Effusion Drainage Kits and the Aspira® Peritoneal Drainage System currently marketed by Bard. Merit understands these products are currently sold primarily in the United States.

Cardinal Health to divest China unit for $1.2B

Cardinal Health has inked a $1.2 billion deal to offload its Cardinal Health China business to Shanghai Pharmaceuticals. The transaction is slated to close by the end of Cardinal’s fiscal year in June.The sale includes Cardinal’s pharma and medical products distribution units in China, according to a statement. It does not affect the company’s other businesses in China, including Cordis, its Patient Recovery business recently acquired from Medtronic and its medical sourcing team.

Stryker wins HDE approval for aneurysm-treating stent system

The FDA approved Stryker’s stent system that, along with neurovascular embolic coils, treats multiple types of aneurysm. The nod comes under a humanitarian device exemption (HDE).The Neuroform Atlas device is a small nitinol stent used in conjunction with neurovascular embolic coils to treat wide neck, intracranial, saccular aneurysms. Aneurysms occur when part of an artery wall weakens and widens or balloons out.

World’s first human head transplant

world’s first human head transplant has allegedly been performed on a corpse in an 18 hour operation which successfully connected the spine, nerves and blood vessels of two people.The operation was carried out by a team led by Dr Xiaoping Ren of Harbin Medical University, China, who last year successfully grafted a head onto the body of a monkey.Italian Professor Sergio Canavero, Director of the Turin Advanced Neuromodulation Group, who has been working with the team, said they would ‘imminently’ move onto a living human who was paralysed from the neck down.He told The Telegraph that electrical stimulation of the nerves proved the operation on the corpse had been successful, and that the two people had been completely attached.

DynamX, a Novel Stent That Turns from Rigid to Flexible While Inside Vessel

Elixir Medical, a Milpitas, California firm, has developed a drug eluting stent that structurally behaves the same as a traditional metal stent, but after a few months becomes more flexible, allowing pulsatile motion to take over the vessel. The so-called bioadaptive DynamX cobalt chromium stent has special flexible segments throughout its architecture that are held rigid by the polymer that releases the Novolimus antiproliferative drug embedded in it. The polymer is slowly eaten away by the body, releasing the drug, but also eventually letting loose the flexible segments. Once these segments are freed, they change the dynamics of the stent, making it significantly more pliable. Beside helping to liberate the vessel to move naturally, the new design may help avoid fractures to the stent itself, a fairly common occurence.

Owens and Minor to buy Halyard Health’s surgical business for $710m

Owens and Minor has entered a definitive agreement to purchase Halyard Health’s surgical and infection prevention (S&IP) business for a cash consideration of around $710m.The complementary business is expected to boost Owens and Minor’s global business and product portfolio, while it will expand the presence of its network to additional markets and channels.The acquisition will also add new skill sets, resources and capabilities required to support growth initiatives of the firm.

Abbott gets CE-Mark for new-generation XIENCE stent

The new design, delivery system and size of the new XIENCE Sierra stent are intended to improve the ability to access and unblock clogged arteries in complicated cases.XIENCE Sierra features a thinner profile, enhanced flexibility, longer lengths and small-diameters, enabling doctors to use less force during implantation of the stent.

BD to sell  2 subsidiaries to complete Bard acquisition

Becton Dickinson & Co. has secured anti trust approval in the European Union for its $24 billion acquisition of C.R. Bard (NYSE:BCR) after selling 2 subsidiaries to remove concerns over competition, according to a Reuters report.Concessions included a pledge from BD to sell its global core needle biopsy device division and an in-development tissue marker device, according to the report.Late last month, Franklin Lakes, N.J.-based Becton Dickinson said it offered concessions to address certain EU antitrust concerns in its acquisition of Bard, according to the European Commission.

Becton Dickinson offers EU concessions over $24 bln Bard deal

U.S. medical equipment supplier Becton Dickinson and Co has offered concessions to address EU antitrust concerns over its $24 billion bid for U.S. peer Bard, the European Commission said on Thursday.The deal, announced in April, is the latest in the medical device sector as companies seek to offset slowing revenue growth, consolidation among healthcare providers and rising pressure from customers to hold down treatment costs.Becton Dickinson submitted its concessions on Sept. 27, a filing on the EU competition authority showed. It did not provide details, in line with its policy.Companies typically offer to give rivals access to key technologies or sell off overlapping units to ease regulatory concerns.The Commission extended its deadline for a decision to Oct. 18 from Oct. 4. It can demand more concessions or open a full-scale investigation of about four months if the companies fail to allay its concerns.

Duodenoscope With Disposable Distal Cap Said to Be Easier to Reprocess

The FDA says the disposable cap will improve access for cleaning and reprocessing. The FDA has approved a newly designed duodenoscope from Pentax Medical called the ED34-i10T which features a single-use, disposable distal cap — a feature the agency says will improve access for cleaning and reprocessing and lower the risk of future infections associated with duodenoscopes.Duodenoscopes, which are used for endoscopic retrograde cholangiopancreatography (ECRP) procedures, have been linked to numerous deadly outbreaks in recent years, and their complex design makes them extremely challenging to sterilize.

Abbott Stop Absorb bioresorbable scaffold in all countries

The company announced its intention to stop selling the bioresorbable scaffold in all countries as of September 14, 2017 but said follow-up of existing studies will continue. The decision was based on “low commercial sales.” The decision applies to all countries, not only the United States. Both the Absorb and the Absorb Gt1 Bioresorbable Vascular Scaffold Systems are being discontinued. Absorb accounted for less than 1% of Abbott’s stent sales around the world,Abbott is working for the second-generation device that has a thinner profile and is easier to deliver.

FDA updates gastric balloon warning after 5 deaths

The FDA updated its warning on liquid-filled intragastric balloons used to treat obesity after receiving five new reports of patient deaths.Four of the patients were implanted with Apollo Endosurgery’s Orbera balloon, while the fifth was implanted with ReShape Medical’s Integrated Dual Balloon System. Intragastric balloons are designed to treat obesity by taking up room in the stomach, making patients feel full.In three of the reports, the patients died within three days of device placement, while in the other two, the patients died within one month of the procedure, the FDA said.“At this time, we do not know the root cause or incidence rate of patient death, nor have we been able to definitively attribute the deaths to the devices or the insertion procedures for these devices,” the agency said.

FDA approve first MRI device for newborns

Aspect Imaging has earned an FDA nod for its neonatal magnetic resonance imaging (MRI) device, designed for head and brain imaging in neonatal intensive care units.While MRI scanners may be used to image newborns, transporting babies out of the NICU to the MRI can put them at risk, said Vasum Peiris, M.D., chief medical officer for the pediatrics and special populations at the FDA’s Center for Devices and Radiological Health, in a statement. “Having a system in the neonatal intensive care enables safer imaging for this vulnerable patient population.”Unlike a traditional MRI, the Embrace Neonatal MRI system does not need a radiofrequency shielded room or a safety zone, so it can be placed in the NICU. It also incorporates a temperature-controlled incubator that is placed directly into the machine to minimize the infant’s movement.

Philips to buy medical device maker Spectranetics for 1.9 billion euros

Dutch healthcare company Philips  has agreed to buy U.S.-based Spectranetics Corp, a maker of devices to treat heart disease, for 1.9 billion euros ($2.16 billion) including debt, as it expands its image-guided therapy business.Spectranetics uses techniques including lasers and tiny drug-covered balloons to clean the insides of veins and arteries that have become clogged due to heart disease.Philips will pay Spectranetics shareholders $38.50 per share, a 27 percent premium to their closing price on June 27.

Bard shareholder looks to scuttle $24B merger with BD

A shareholder of C.R. Bard  sued yesterday to stop a $24 billion merger with Becton Dickinson  arguing that the price tag is too low and that the sale process was flawed and seeking class-action status for the suit.Plaintiff Richard Maser filed the lawsuit in the U.S. District Court for New Jersey, seeking to block the deal until the companies disclose more facts about their negotiations. Maser alleged that the agreement’s “no solicitation” clause “prohibits the company or the individual defendants from taking any affirmative action to obtain a better deal for Bard shareholders.

Thermo Fisher to buy Patheon for $5.2 billion to expand biopharma services

Thermo Fisher Scientific Inc (TMO.N) said on Monday it would buy Patheon NV (PTHN.N), a Dutch manufacturer of drugs for clinical trials, for $5.2 billion as it seeks to complement its offerings in production and services for the biopharma industry.The offer price of $35 per share represents a premium of about 35 percent to Patheon’s Friday close. Thermo will also assume $2 billion in net debt, putting the cost of the deal at about $7.2 billion for Patheon, which generated $1.9 billion in revenue last year.Thermo Fisher, the world’s largest maker of scientific instruments, also supplies raw materials used in formulating experimental drugs and had been doing business with Patheon.

Cook Medical’s magnetic esophageal repair device for infants earns FDA approval

The FDA has authorized the use of Cook Medical’s device for the treatment of infants born with a defect that causes a gap in the esophagus. It was OK’d via the agency’s Humanitarian Device Exemption pathway.The Flourish device is designed to treat esophageal atresia in infants up to one year old. The congenital defect, where the esophagus grows in two separate segments, makes it impossible for babies to feed normally. It is lethal unless it is treated, according to Boston Children’s Hospital. It is usually treated by surgically connecting the two ends of the esophagus. They are fed intravenously until the gap can be repaired.

Abbott wins reimbursement for glucose monitoring device in France.

Abbott has secured reimbursement for its FreeStyle Libre glucose monitoring technology in France. The nod positions Abbott to grow sales of the noninvasive blood glucose monitoring device in a country that is already the second-biggest market for the technology globally.FreeStyle Libre came to market in Europe in 2014 but it has taken time for Abbott to get healthcare systems across the continent’s fragmented payor landscape to cover the device. The addition of France to the list of countries in which the wearable sensor-based glucose monitoring technology is covered means the device is now fully or partly reimbursed in 13 nations.

Boston Scientific gets FDA nod for long-life cardiac implant

Boston Scientific has received FDA approval for its Resonate line of high-voltage cardiac devices. The regulatory nod clears Boston Scientific to start selling devices it thinks can overcome reticence among physicians to use multipoint pacing products by diminishing concerns about battery life.FDA gave its approval to Boston Scientific’s Resonate line of implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillator (CRT-D) systems. The products all use the EnduraLife battery, a technology Boston Scientific claims has twice the capacity as that used by Medtronic in its Evera XT VR DVBB2D4 device. Boston Scientific has made battery life the centerpiece of its push to sell Resonate devices in Europe.

BD TO ACQUIRE BARD FOR $24 BILLION

BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, and C. R. Bard, Inc. (NYSE: BCR), a medical technology leader in the fields of vascular, urology, oncology and surgical specialty products, announced today a definitive agreement under which BD will acquire Bard for $317.00 per Bard common share in cash and stock, for a total consideration of $24 billion. The agreement has been unanimously approved by the Boards of Directors of both companies. The combination will create a highly differentiated medical technology company uniquely positioned to improve both the process of care and the treatment of disease for patients and healthcare providers. The transaction will build on BD’s leadership position in medication management and infection prevention with an expanded offering of solutions across the care continuum. Additionally, Bard’s strong product portfolio and innovation pipeline will increase BD’s opportunities in fast-growing clinical areas, and the combination will enhance growth opportunities for the combined company in non-U.S. markets.

Patient at Mediclinic City Hospital Receives Revolutionary Radiotherapy Treatment

A 42-year-old female diagnosed with liver metastases has become the first cancer patient at Mediclinic City Hospital to be treated with a revolutionary form of radiotherapy called stereotactic body radiotherapy (SBRT). Performed at Mediclinic City Hospital’s newly-opened Comprehensive Cancer Centre (CCC), Dubai’s most advanced facility for the diagnosis and treatment of cancer, this technique is designed to decrease the overall treatment time from several weeks to just five individual sessions. Delivered by Mediclinic’s True Beam Varian linear accelerator, the only one of its kind in the UAE, SBRT is used for tumours that occur in locations that would be otherwise difficult to treat, by using advanced immobilisation devices to maintain the patient’s position and deliver radiation with millimetric precision.

Roche launches new prostate cancer diagnostic test

Swiss diagnostic firm Roche has launched a new test called anti-p504s (SP116) Rabbit Monoclonal Primary Antibody for the diagnosis of prostate cancer.Intended for the use in laboratories, the anti-p504s (SP116) Rabbit Monoclonal Primary Antibody is designed to detect α-methylacyl-CoA racemase (AMACR) in formalin-fixed, paraffin-embedded (FFPE) tissue sections.The new tool is validated for use with a dual stain and VENTANA Basal Cell Cocktail (34ßE12+p63) to enable easy differentiation of morphologically difficult cases such as benign, atypical or cancerous on a single slide.The in-vitro diagnostic (IVD) primary antibody can be used on the automated slide stainers of the VENTANA BenchMark IHC/ISH series

Acelity launches new non-surgical dressing for cleaning wounds

US-based medical device company Acelity has launched a new adjunctive non-surgical dressing, VAC Veraflo Cleanse Choice, that can be used to clean large complex wounds.Combined with the firm’s negative pressure wound therapy and instillation (NPWTi-d) system called VAC Veraflo Therapy, the new dressing is expected to allow rapid cleansing when complete surgical debridement is not possible or appropriate.The dressing comes with a three-layer foam design, enabling selective cleaning of affected tissue and infectious materials.It features a contact layer designed to provide mechanical movement at the surface of the wound, as well as two cover layers that enable application on wounds with different depths.

Endologix begins enrolment in ELEVATE IDE study of Ovation Alto for aortic disorders

US-based Endologix has started patient enrolment in expanding applicability with polymer sealing ovation alto stent graft (ELEVATE) investigational device exemption (IDE) as part of a clinical study of the Ovation Alto to repair infrarenal abdominal aortic aneurysms (AAAs).A part of the firm’s Ovation platform, Ovation Alto is a abdominal stent graft system designed to expand the endovascular aneurysm repair (EVAR) for treating more patients on IFU.The ELEVATE study will assess the safety and effectiveness of the device in 75 patients at up to 12 centres in the US.Endologix chief executive officer John McDermott said: “The first patients enrolled in the ELEVATE IDE represent an important milestone for the company, as we continue to advance our portfolio of innovative technologies for the treatment of AAA.

Cardinal Health closes in on $6B deal for Medtronic’s medical supplies 

Cardinal Health is closing in on a deal to pay $6 billion to acquire the medical supplies business Medtronic  picked up when it paid $50 billion for Covidien in January 2015.Citing “people familiar with the matter,” Reuters reported that exclusive talks between the companies could result in an announcement later this month. Medtronic and Cardinal Health declined to comment to the wire service. The division makes general medical equipment including monitoring equipment, medical instrumentation, needles and other basic supplies.

Abbott to restrict Absorb bioresorbable stent in Europe

Abbott  plans to restrict the use of its Absorb bioresorbable stent in Europe after a clinical study found a higher risk of serious adverse events.In a March 31 letter to physicians (posted online April 5 by a prominent cardiologist from Atlanta), Abbott said it would restrict use of the Absorb and Absorb GT1 devices to clinical registry studies as of May 31.

iVascular Capturer 7F granted CE mark

The company claims that the device has outstanding extraction capacity, and the highest aspiration speed capability on the market. It is compatible with standard 0,014’’ guidewires, and is indicated for the manual extraction of fresh, soft thrombi from coronary and peripheral vasculature.Capturer 7F is an addition to the existing company range, which includes the Capturer 6F.

Medtronic updates troubled SynchroMed infusion pump in class 1 recall

Medtronic is updating the software for its SynchroMed implantable infusion pumps due to a software issue that could cause the devices to deliver too much or too little of a drug. The action is deemed a class 1 recall by the FDA.

Boston Scientific touts 3-year outcomes for Synergy bioabsorbable drug-eluting stent

Data presented at ACC 2017 showed that Boston Scientific‘s Synergy bioabsorbable polymer drug-eluting stent was as efficacious as the company’s Promus Element Plus drug-eluting stent system, with a lower relative rate of stent thrombosis.The 3-year Evolve II trial enrolled 1,684 patients with native coronary artery lesions and randomized patients to receive either the Synergy or Promus stent. The primary endpoint was target lesion failure at 12 months.

ACC 2017 Roundup: Medtronic’s CoreValve as good as surgery in intermediate-risk trial

A study comparing surgical valve replacement with transcatheter aortic valve replacement using the CoreValve device made by Medtronic (NYSE:MDT) showed that the TAVR device was as safe as surgery in intermediate-risk patients, according to data presented today at ACC 2017.Two-year data from the 1,657-patient Surtavi study, presented at ACC 2017 and published in the New England Journal of Medicine, showed non-inferiority for the CoreValve implant for an endpoint combining all-cause mortality and disabling stroke, with the TAVR device showing a 12.6% rate compared with 14% for surgical intervention. The rate of death was 11.4% for TAVR and 11.6% for surgery; the rate of disabling stroke was 2.6% for the TAVR cohort and 4.5% for the control group.

Medtronic wins expanded FDA indication for Melody TPV

Medtronic said today it won extended FDA approval for its Melody transcatheter pulmonary valve, now indicated for implantation in patients whose surgical bioprosthetic pulmonary heart valves have failed.

Stryker launches Mako robotic platform total-knee application

Stryker said today it launched the robotic-arm assisted total knee arthroplasty application for use with its Mako System, touting it as the 1st and only robotic technology which can be used for total knee, hip and partial knee replacement procedures.

 

ZOLL’s Hospital Wearable Defibrillator FDA Approved

ZOLL Medical, now a part of Asahi Kasei, a Japanese corporation, received FDA approval to introduce its Hospital Wearable Defibrillator (HWD) in the U.S. Intended for use on patients that may exhibit ventricular tachycardia or ventricular fibrillation (VT/VF) during their hospital stay

The FDA approved Tryton Medical’s stent for the treatment of coronary bifurcation lesions

FDA OKs Tryton Medical’s stent for coronary bifurcation lesions, or cases of coronary artery disease where plaque accumulates where an artery branches from another.Coronary artery disease is the most common form of heart disease, according to the Centers for Disease Control and Prevention. CAD, characterized by the buildup of plaque in the coronary arteries, can lead to angina or a heart attack, and leads to more than 370,000 deaths in the U.S. each year, the CDC says.

Bluegrass Vascular Technologies has entered into a strategic relationship with Merit Medical Systems.

Bluegrass Vascular Technologies, a private medical technology company that relocated its headquarters from Lexington, Kentucky, to San Antonio in 2014, has entered into a strategic relationship with Merit Medical Systems.The new deal with Utah-based Merit will give Bluegrass Vascular streamlined distribution of its Surfacer Inside-Out Access Catheter System in Europe and is also expected to provide funding to support efforts to secure U.S. federal regulatory approval for its initial device 

CeloNova Biosciences Receives FDA Approval of COBRA Pz Stent System

CeloNova BioSciences, Inc. announced that it has received U.S. Food and Drug Administration (FDA) approval for the COBRA PzF NanoCoated Coronary Stent System.Regulatory approval of the stent system was based on findings from the pivotal PzF SHIELD clinical trial, which successfully met its primary safety and effectiveness endpoints at nine-month follow-up, demonstrating no stent thrombosis and low clinically driven target lesion revascularization (TLR) of 4.6 percent. Coated with a proprietary nano-thin polymer that is designed for biocompatibility, the COBRA PzF stent requires a minimum 30-day dual antiplatelet therapy (DAPT) regimen following intervention.

FDA clears ViewRay’s next-gen, MRI-guided radiation therapy device

ViewRay earned an FDA nod for its MRIdian Linac system, the first device to hit the market that combines MRI guidance with linear accelerator radiation. It allows physicians to visualize in real time the movement of tumors and organs during radiation treatment.

Philips gets FDA nod for noninvasive liver assessment

Philips has received FDA 510(k) clearance for its noninvasive test of liver tissue stiffness. The FDA nod (PDF) positions Philips to pitch its ultrasound ElastQ Imaging offering as an alternative to biopsies for physicians assessing damage from liver diseases including hepatitis C and NASH.

FDA OKs Velano Vascular’s next-gen needle-free blood draw device

The FDA cleared Velano Vascular’s second iteration of its needle-free blood draw device, which attaches to the peripheral IV line that most hospital patients already have, cutting down on repeated needle sticks that are the norm for blood collection.

FDA clears Accelerate Diagnostics’ bloodstream infection test

Accelerate Diagnostics earned 510(k) clearance for a test that identifies the organism behind bloodstream infections and provides information about its antibiotic sensitivity.The PhenoTest BC Kit, which runs on the company’s Pheno System, is the first test to identify the bacteria or yeast behind a blood infection and supply information about which antibiotics it is likely to respond to, the FDA said in a statement.It identifies 14 species of bacteria and two species of yeast and provides antibiotic sensitivity information on 18 antibiotics, the FDA said. The test works by comparing the DNA of the infection-causing bacteria or yeast to DNA that is unique to specific organisms. The organism is then mixed with different antibiotics to determine which ones curb the organism’s growth.

Philips launches new image-guided therapy platform Azurion

Netherlands-based health technology company Royal Philips has expanded its existing portfolio of solutions with the launch of new image-guided therapy platform Azurion.Meant for use in the interventional labs, Azurion features an ergonomic design with an easy-to-use user interface and is equipped with new workflow options, performance dashboards, as well as a range of productivity improvement services.

Biotronik secures FDA approval for PRO-kinetic coronary stent system

Biotronik has secured the US Food and Drug Administration (FDA) approval for its PRO-kinetic energy cobalt chromium (CoCr) coronary stent system, based on the results from the BIOHELIX-I clinical study.Designed to increase coronary luminal diameter in patients with new and reoccurring blockages in the coronary arteries, the bare-metal stent has already been used to treat more than 650,000 patients.

 

Integra LifeSciences has made a binding offer to acquire Johnson & Johnson’s Codman Neurosurgery business for about $1.05 billion in cash.

Codman, which reeled in about $370 million in revenue last year, is part of J&J’s DePuy Synthes group. If J&J accepts the bid, Integra will boost its neurosurgical offerings, getting its hands on surgical devices used to treat brain tumors, hydrocephalus (or the buildup of fluid in the brain) and other neurological disorders.Codman’s “innovative portfolio and global reach will enable us to enhance our position in the neurosurgery market, while also building a global infrastructure that will benefit Integra as a whole,” said Integra CEO Peter Arduini in a statement. “We look forward to welcoming the more than 600 Codman Neurosurgery employees to the Integra team.”Integra’s neurosurgery stable includes flow-regulating valves to control the flow of cerebrospinal fluid and a dural sealant system. It has devices for tissue ablation, dural repair and cranial stabilization in its pipeline, according to the statement.

Medtronic thinking to sell medical supplies business for $5B

Medtronic has enlisted advisers to prepare the sale of its medical supplies business, in whole or in parts, according to sources quoted by Bloomberg. A deal could bring in as much as $5 billion.The company was said to be scouting prospective buyers, but whether the devicemaker will offload the business in one go or sell it off in multiple deals is still up in the air. The sources asked not to be identified as the matter is not public, Bloomberg reported.The medical supplies unit posted $500 million in earnings before interest, taxes, depreciation and amortization, and people familiar with the matter said it would likely sell for eight to 10 times that amount, Bloomberg reported.

FDA approved MRI-conditional labeling for Abbott’s tiny wireless pacemaker

The company picked up the Assurity MRI pacemaker and the Tendril MRI pacing lead in its acquisition of St. Jude Medical, which closed earlier this month. The pacemaker allows physicians to wirelessly monitor their patients, which can reduce the need for office visits

 

FDA approved W.L. Gore’s balloon expandable stent graft for use in the iliac artery

The FDA approved W.L. Gore’s balloon expandable stent graft for use in the iliac artery, making it the first and only device of its kind approved to treat peripheral artery disease in this part of the body.Peripheral artery disease affects as many as 9 million people in the U.S., according to the American Heart Association.

Tack Endovascular System Cleared in Europe for Repair of Arterial Dissections Below Knee

Following a balloon angioplasty, an artery can sometimes develop a dissection, a potentially serious complication. The Tack endovascular system from Intact Vascular, a Wayne, Pennsylvania firm, received the CE Mark in Europe to be used to repair arterial dissections such as this in tibial arteries below the knee. The Tack consists of tiny stent-like implants and a delivery system that places them at arterial dissection sites. The stents can support arteries from 1.5 mm to 4.5 mm in diameter, so there’s not much need for sizing. Some comments from Intact Vascular regarding what led to the CE Mark clearance.

Cook Unveils New Two-in-One Wire Guide for Urological Procedures

Cook Medical has unveiled a so called “two-in-one” wire guide for urologists that often end up using two wire guides in one procedure. The Motion Hybrid features nitinol, a memory alloy, as an access wire guide, and Teflon for the fixed core wire guide, all in one device. This can speed up procedure times since there’s fewer wire guide exchanges necessary.

 

Terumo Acquires Bolton to Accelerate Growth of Its Vascular Graft Business

Terumo Corporation) today announced that it has entered into a definitive agreement under which Terumo has agreed to acquire Bolton Medical, Inc. from its parent company. Bolton Medical is a leading innovator in thoracic and abdominal stent graft systems.”The acquisition will enhance Terumo’s existing product portfolio in the global stent graft market and our vascular graft business will be further strengthened in the US, in what is the largest stent graft market today.” said Shinjiro Sato, President of Cardiac and Vascular Company, Terumo Corporation.The transaction is expected to close in a few months and it will be funded through cash on hand and debt. The closing is subject to antitrust clearance and other customary closing conditions. The impact of the acquisition on Terumo’s financial is currently being scrutinized

Abbott Announces CE Mark for its „Alinity s” Blood and Plasma Screening System

Abbott announced today its Alinity™ s System for blood and plasma screening received CE Mark and is now available in Europe and other countries that recognize CE Mark. The new testing solution is designed to screen blood and plasma faster and more efficiently within a smaller footprint than Abbott’s current systems. In a testing specialty that can require extensive hands-on time, the additional automation and flexibility of the Alinity s System helps blood and plasma centers improve productivity and maintain the highest levels of accuracy, without expanding the instrument footprint.

FDA approves Alcon’s AcrySof IQ ReStor intraocular lens

Novartis‘ eye care business, Alcon, said today that it won FDA approval for its AcrySof IQ ReStor multifocal toric intraocular lens. The lens treats presbyopia and pre-existing corneal astigmatism in adult patients undergoing cataract surgery.

NMC Health will acquire  Al Zahra Hospital

NMC Health announced the proposed acquisition of Al Zahra Hospital in Sharjah from Gulf Medical Projects Company for Dh2.05 billion ,The healthcare provider said the acquisition will complement the group’s existing network of seven out-patient medical centers in Sharjah and will reinforce the company’s position as a leading provider of healthcare services in the UAE’s private sector.

Al Zahra Hosptial has achieved revenues of $130.4 million and net profit of $38.8 million for the year ended December 2015.

J&J’s LifeScan wins FDA clearance for WellDoc integration of blood glucose data

Johnson & Johnson subsidiary LifeScan said today it won FDA clearance for wireless integration of its OneTouch Verio Flex blood glucose monitoring system with WellDoc‘s FDA-approved BlueStar diabetes management system.The OneTouch Verio Flex system is now cleared to automatically wirelessly transmit blood glucose monitoring data to WellDoc’s BlueStar system, which in turn provides patients with real-time feedback and virtual coaching based on patient specifics. The system also keeps the patient’s health care teams informed of their status for better decision making

FDA clears St. Jude Medical’s EnSite Precision heart map, Advisor FL catheter

St. Jude Medical (NYSE:STJ) said today that it won 510(k) clearance from the FDA for its EnSite Precision cardiac mapping system and the Advisor FL catheter used with it.The Ensite cardiac mapping system is designed for use in ablation procedures to visualize and aid in catheter navigation in the heart, providing detailed anatomical models and maps, St. Jude said. The system is designed to aid in diagnosing arrhythmias, guiding therapy and providing expanded procedural options.

Philips is selling a majority stake of its lighting business, Lumileds, to Apollo Global Management for $2 billion

he deal comes nearly a year after the company’s bid to offload Lumileds to a Chinese firm fell through due to pressure from U.S. regulators.The deal will see Apollo picking up an 80.1% stake in Lumileds, with Philips holding onto the remaining 19.9%, according to a statement. While it values the lighting and automotive business at $2 billion, Philips expects to pick up about $1.5 billion in cash. The transaction is slated to close in the first half of 2017, subject to regulatory approval.

ConvertX  Nephroureteral  Stent System Avoids Extra Procedure won FDA clearance

BrightWater Medical, a company based in Murrieta, California, won FDA clearance to introduce in the U.S. its ConvertX nephroureteral catheter and stent system for use in treating ureteral obstructions in patients that require perc nephrostomy tubes. The system is intended to be used by interventional radiologists and removes a separate minimally invasive procedure that is required with current treatment.convertx-2Right now, a nephrostomy catheter is first placed to drain urine into a bag. The patient comes back a few days later to have the catheter removed and a stent placed. The ConvertX is designed to have the stent delivered during catheter placement and expanded once drainage is complete. The catheter essentially transforms into a stent in a quick follow up procedure without needing fluoroscopy or sedating the patient. Once finalized, the stent works like other existing ureteral stents.

Dubai rolls out new health insurance payment system

The Dubai Health Authority (DHA) said on Tuesday it would adopt a new health insurance payment system across the emirate.Under the new system, payments to hospitals will be based on the level of care required and hospital resources, rather than the patient’s length of stay.The new system uses statistics for classifying inpatient stays into groups for payment purposes.It also has a medical inflation indicator that caters to increases in cost for the medical sector, which can produce indicators of inflation particular to health care.Humaid Al Qatami, DHA chairman and director-general, said the system would help Dubai’s health providers adopt a clear pricing method, allowing hospitals and clinics to provide fair prices, The health body’s executive council approved the implementation of the system, called the International Refined Diagnosis-Related Group (IR DRG).It will be implemented within three years starting 2017 and ending in 2019, in order for hospitals and clinics to adapt.

 

Teleflex to acquire Vascular Solutions for $1B

Teleflex has inked a deal to acquire Vascular Solutions for $1 billion, picking up devices for minimally invasive coronary and peripheral vascular procedures and gaining entry into those markets.Teleflex operates across a range of areas, offering cardiac care, respiratory, interventional access and surgical products. The Vascular Solutions acquisition will boost Teleflex’s vascular and interventional divisions. The deal is slated to close in the first half of next year.

B Braun announces collab deal with Omnicell  

Braun said this week it inked a collaborative deal with Omnicell to help decrease the time and clinical support necessary to manage IV infusions and IV compounding.Through the deal, Omnicell will be able to use B. Braun’s DoseTrac infusion management software through a hyperlink in Omnicell’s performance center, the companies said.

iBreastExam: Low Cost, Point-of-Care Breast Health Test

UE Lifesciences, a company with offices in the U.S. and India, has developed the iBreastExam, a low-cost point-of-care breast health test for use by community workers in low resource settings. This device is designed to address the rising incidence of breast cancer in developing countries where women have limited or no access to breast cancer screening services.

 Abbott won European CE Mark approval for its i-STAT Alinity blood testing system.

It’s a portable point-of-care device that can be used to test for a variety of metabolites, including blood chemistries and cardiac biomarkers. It works off of only two or three drops of blood and displays results within ten minutes, depending on the assay used.

Dallas jury commanded Johnson & Johnson to pay up $1 billion

A Dallas jury commanded Johnson & Johnson to pay up $1 billion to plaintiffs claiming injury from from the company’s metal-on-metal hip implants. This follows a $500 million verdict concerning the same implants, handed down in March this year.

Spectranetics scores CE mark for PAD drug-coated balloon

Spectranetics picked up a CE mark for an even smaller iteration of its drug-coated angioplasty balloon. This one is designed to treat small vessels, below-the-knee peripheral artery disease (PAD) and critical limb ischemia (CLI).

Ascensia’s smart glucose meter and app combo wins FDA nod

The FDA cleared Ascensia Diabetes Care’s latest glucose monitoring system, comprising a smart blood glucose meter and app to help patients better understand and manage their diabetes.The Contour Next One’s smart meter connects to a mobile device and app via Bluetooth. The meter delivers blood glucose data to the Contour Diabetes app, which gathers, stores and analyzes it to recognize trends that may help patients understand their condition better, according to a statement.

FDA Approve new indication for Medtronic’s Solitaire stent retriever

DA granted 510(k) clearance for an expanded indication for its Solitaire stent retriever.The new indication covers its use as an initial treatment for acute ischemic stroke after the dministration of intravenous tissue plasminogen activator and within six hours of symptom onset.

Smith & Nephew recalls Modular SMF, Modular Redapt hip implants

Smith & Nephew this week recalled its Modular SMF and Modular Redapt hip implants “due to a higher than anticipated complaint and adverse event trend” with the modular necks used in the devices.

Xenocor wins CE Mark for low cost Xenoscope laparoscope

Laparoscopic device developer Xenocor said today it won CE Mark approval in the European Union for its single-use Xeonoscope laparoscopic systems. The device is now indicated for use in diagnostic and therapeutic procedures for endoscopy and endoscopic surgery within the thoracic and peritoneal cavities, including the female reproductive organs.

Boston sci acquires single-use uterine polyp remover from Distal Access

Boston Scientific is picking up a single-use device for the removal of uterine polyps in its acquisition of Distal Access’ gynecology and urology portfolio, The Resectr is a disposable, nonpowered, hand-held device that is compatible with various hysteroscopes. It is used for the treatment of uterine polyps in a doctor’s office, hospital or ambulatory surgery center. Uterine polyps, which can cause abnormal bleeding and infertility, affect as many as 80% of women. More than 400,000 polypectomies are done each year in the U.S..

 

FDA approves Medtronic defibrillator that automatically adjusts pacing

The FDA approved Medtronic’s defibrillator that tailors cardiac resynchronization therapy (CRT) to each patient by using an algorithm to adjust pacing. With its ability to confirm if pulses are effective, it has a leg up over other CRT devices, which can only report that a pulse was sent.

Becton Dickinson launched a new syringe specifically for use with Eli Lilly’s concentrated insulin                                    Becton Dickinson announce  manufacture of new syringe specifically for use with Eli Lilly’s concentrated insulin, which is prescribed for diabetics who need to inject higher doses of insulin daily. Previously, patients and physicians had to make do with traditional insulin syringes, which could lead to dosing errors. 

Philips pays $300M, inks pact to end Masimo patent fight                                                                                                               Philips  and Masimo have struck an agreement to end their long-running patent fight. The multipart pact puts the legal scrap between Philips and Masimo to bed while setting them up to combine their respective expertise in patient monitoring and noninvasive sensors.

FDA OKs Arterys’ cardiac MRI analysis software                                                                                                                                      Cloud-based medical imaging player Arterys has earned an FDA clearance for its Arterys software, which can now be used to noninvasively quantify cardiac flow and measure heart function in clinical settings

Boston picks up  endoscopic tissue retractor from LumenR Boston Scientific is bolstering its endoscopy pipeline with the acquisition of an in-development tissue retractor from Newark, CA’s LumenR. The system is intended for the endoscopic removal of lesions in the gastrointestinal tract.The LumenR Tissue Retractor System is designed to enhance endoscopic submucosal dissection (ESD) and endoscopic mucosal resection (EMR) procedures by providing improved visualization of lesions and a stable working environment

Medtronic presents positive 30-day CoreValve Evolut R data at TCT Medtronic unveiled new 30-day data for its recapturable and repositionable transaortic valve replacement at this year’s Transcatheter Cardiovascular Therapeutics (TCT) meeting. The device earned FDA approval in June last year.

Corindus Unveils CorPath GRX, a New Robotic PCI System Corindus Vascular Robotics, a company based in Waltham, MA, won FDA clearance to introduce its CorPath GRX robotic angiography system. The new generation of the CorPath system is intended to make robotically-assisted angioplasties even more precise, make operation faster for shorter procedure times, and allow for more patients to be treated with it. An intuitive interface and comfortable seating help the physician speed up delivery and placement of the instruments. The actual robotic unit that stands by the patient has been redesigned and includes a touchscreen display that shows relevant information during procedures

St. Jude Medical won FDA approval to introduce its AMPLATZER PFO Occluder  atent foramen ovale (PFO) is present in up to 25 percent of the general population. Although it’s asymptomatic for most people with the condition, and most don’t even know they have it, some with PFO can suffer from repeat ischemic strokes. St. Jude Medical won FDA approval to introduce its AMPLATZER PFO Occluder that can help prevent recurrent ischemic strokes by closing the passageway between the atria.

Medtronic celebrates positive study results for drug-eluting stent The data from the independent BIO-RESORT study showed that the company’s Resolute Integrity drug-eluting stent (DP-DES) performed as well as a biodegradable polymer stent in treating patients with coronary artery disease. The results were presented recently at the Transcatheter Cardiovascular Therapeutics Annual Meeting and published in The Lancet.

St. Jude warns of more battery problems with another of its cardiac devices For the second time in a month, St. Jude Medical has issued a warning of possible problems with one of its implantable heart devices. This time the company has told doctors to cease using its Nanostim leadless cardiac pacemakers.

DePuy Synthes unveils new surgical imaging system that cuts costs J&J’s DePuy Synthes unveiled its latest surgical imaging offering that’s designed to be more affordable in hopes of opening up access to advanced imaging tech.Dubbed the KICK System with FluoroExpress Software Module, the package is compatible with the VIPER System and the EXPEDIUM Spine System of implants, and improved visualization during minimally invasive and open procedures to treat a broad range of spinal disorders

Svelte DIRECT RX Rapid Exchange Drug Eluting Stent System Cleared in Europ Svelte Medical, a company with offices in New Providence, NJ and Brussels, Belgium, won the European CE Mark for its DIRECT  Sirolimus-Eluting Coronary Stent Rapid-Exchange (RX) System. svelte-stentThe implant features sirolimus embedded within a proprietary amino acid-based polyesteramide material that slowly biodegrades while letting the drug seep out. The system can be used for direct stenting, without a separately delivered balloon, since its own high pressure balloon and the tough coating allow for thorough expansion of the blocked lumen. This can reduce procedure times and lead to better results for patients while allowing for faster turnover in the cath lab.

Medtronic’s SureScan Cardiac Implants Approved for 3T MRI Scans Anywhere on Body Medtronic won FDA approval to allow patients with its SureScan MR-conditional pacemakers, implantable cardioverter-defibrillators (ICDs), cardiac resynchronization therapy-defibrillators (CRT-Ds), and accompanying leads, to receive up to 3 Tesla MRI scans over any part of the body.

Getinge says to spin off and list smallest division as Q3 profit lags Swedish medical technology firm Getinge said on Tuesday it planned to spin off and list its smallest division, renamed Patient and Post-Acute Care, as it reported a smaller profit than expected for the third quarter.”Getinge has decided to focus on two business areas, Acute Care Therapies and Surgical Workflows,” it said in a statement.”The future listing of Patient & Post-Acute Care will increase the ability of both companies to realise their strategies and to best continue to enhance customer benefits and shareholder value,” it said.The Patient & Post-Acute Care unit, formerly called Extended Care, would be distributed to shareholders with a listing planned for no later than the first quarter of 2018, the company said.

Boston Scientific is launching a new endoscopic hemostatic clipping device  Resolution 360, generally intended for use in the GI tract to remove polyps, treat peptic ulcers, and work on diverticuli of the colon. As down-the-scopethe name implies, it allows for complete rotation in both directions of the clip at the distal end of the instrument, while being able to open and close the clip at the same time.

Ethicon All-in-One HARMONIC HD 1000i Shears Released in U.S. Ethicon, a part of J&J, is launching in the U.S. its HARMONIC HD 1000i Shears, having received FDA clearance for the device earlier this summer.  The device is intended for surgical procedures requiring high precision craftsmanship, particularly in thoracic and colorectal applications. It can be used in both open and laparoscopic surgeries to disect, transect, and seal tissue without using a separate dissector.

 Philips adds cardiac imaging to smartphone plug-in ultrasound device The FDA cleared Philips’ cardiac transducer for use with Lumify, the company’s smart-device diagnostic ultrasound. The new add-on brings cardiac imaging to the portable diagnostic, which already allows doctors to scan the gallbladder and lungs among other areas.

Medtronic has issued another recall for its Pipeline device used to treat brain aneurysms Dogged by problems with its plastic coating Medtronic inherited the device, which is designed to divert blood from an aneurysm, in its $50 billion acquisition of Covidien. Pipeline was originally developed by Ev3, which Covidien bought in 2010, and got FDA approval in 2011.The problem has dogged the device for several years. Back in 2014, Covidien issued a recall for Pipeline and its companion Alligator embolism retrieval device when reports began to surface that the plastic coating on the guidewire used to reduce friction could delaminate and detach.

Study: Endovascular aneurysm repair shows higher long-term mortality Endovascular repair of abdominal aortic aneurysms showed a higher mortality rate over the long term compared with open surgical repair, according to a study published yesterday in The Lancet.The study, “Endovascular versus open repair of abdominal aortic aneurysm in 15-years’ follow-up of the UK endovascular aneurysm repair trial 1,” was based on data from the 1,252-patient Evar trial 1, in which 626 patients were randomly assigned to either EVAR using a stent graft or open surgical repair. The primary endpoint was total and aneurysm-related deaths through mid-2015.

Scientists Use 3D Printers to Recreate Kidney’s Proximal Tubules At Harvard’s Wyss Institute researchers used a 3D printer to essentially recreate the proximal tubules found within kidneys, potentially opening up the possibility of printing complex structures that can be used to replace diseased tissues and organs.

Xeltis Fully Bioabsorbable Pulmonary Valve Implanted for First Time Xeltis, a Swiss-Dutch firm, announced that its bioabsorbable pulmonary heart valve has been implanted for the first time into three pediatric patients. The trial is investigating the survival rate of patients following right ventricular outflow tract reconstructions using the new device.The company’s pulmonary valve at first works like commonly available prosthetic heart valves, but thanks to the firm’s Endogenous Tissue Restoration (ETR) technology, the device allows patients’ own cells to penetrate it and make home there. As natural tissue takes over, the valve itself slowly degrades and is absorbed by the body. The result is a naturally reconstructed heart having no foreign materials.

FDA clears Fresenius plasma collector, making donation quicker and easier The FDA cleared Fresenius Kabi’s plasma collection system that accelerates the plasma collection process, facilitating plasma donation for donors and center operators alike.Plasma is used in the treatment of burn victims as well as people with bleeding disorders and human immune deficiencies. In plasma donation, a plasmapheresis system draws whole blood via a needle in a donor’s vein. It then separates the plasma from the red blood cells and other cellular components, which are then returned to the donor’s body.

St. Jude’s directional deep-brain stimulation gets FDA OK The FDA approved St. Jude Medical’s deep-brain stimulation device and its directional leads. The first directional leads to earn the FDA nod.

New Vascular Grafts to Grow Along with Patient After Surgery Surgical heart reconstructions using graft materials can do amazing things for patients, but in young children they have a serious limitation. The grafts don’t grow along with a growing heart, and so for procedures such as right ventricular outflow tract reconstructions repeat surgeries are required. Now researchers at University of Minnesota are reporting in journal Nature Communications on newly developed “off-the-shelf” vascular grafts that can grow as the tissue they’re connecting develops and matures.

New Coating Allows for Self-Cleaning Endoscopes That Maintain a Clear View The coating is a modification of SLIPS (Slippery Liquid-Infused Porous Surfaces), a technology developed at Wyss that prevents most materials from sticking to surfaces treated with it. SLIPS makes surfaces effectively self-cleaning, but it had to be modified to survive the chemicals it would encounter within the body and the physical stress that the surface of an endoscope encounters. 

Pfizer offloads Hospira infusion therapy unit to ICU Medical for $1B Pfizer closed its $17 billion acquisition of Hospira just over a year ago, but is already offloading the infusion therapy business in a $1 billion deal. The deal will see ICU Medical picking up all of Hospira’s infusion offerings, including intravenous drugs and infusion pumps.

Siemens scores FDA OK for portable coagulation analyzer Siemens got an FDA nod for its handheld portable coagulation analyzer device. The news is a feather in the company’s cap as it looks to expand its healthcare business.Regulators signed off on Siemens’ Xprecia Stride Coagulation Analyzer, a compact device that looks at Prothrombin Time International Normalized Ratio (PT/INR) to help doctors monitor patients and choose the correct treatment. The analyzer screens fingerstick blood samples to deliver results in minutes, the company said in a statement.

FDA approves St. Jude’s ‘burst’ spinal cord stimulation tech for chronic pain The FDA approved St. Jude Medical’s physician-designed spinal cord stimulation system for the treatment of chronic pain. Treatment with the BurstDR system differs from traditional SCS therapy in that it delivers “burst” pulses of stimulation that mirror the body’s natural nerve impulses.

Edwards gets CE mark for its hypotension indicator  Edwards Lifesciences  has received a CE mark for its hypotension indicator, which alerts healthcare clinicians to the potential of abnormally low blood pressure in surgical and critical care patients before such an event occurs.

DePuy recalls orthopedic surgical tool component because it may explode J&J’s DePuy Synthes is recalling two battery drive adaptors used to power surgical tools–including attachments for the drilling or cutting of bone in orthopedic surgery–because they may explode.

Abbott’s FreeStyle Libre Pro Continuous Glucometry System for Professionals FDA Approved Abbott won FDA approval for its FreeStyle Libre Pro continuous glucose monitoring system, a technology designed to let clinicians get a nuanced view of their patients’ glucose levels

Switch: A Novel Single Handed Suturing Device Unveiled Mellon Medical, a Dutch firm, has unveiled a new suturing device that requires only one hand to operate and that may end up saving a lot of time in the OR the Switch device can suture both tubular structures such as blood vessels and layered tissues like the skin

Medtronic’s New TrailBlazer Angled Support Catheter for PAD Cleared by FDA Medtronic landed FDA clearance for its TrailBlazer angled support catheter that’s indicated for use within the peripheral vasculature for treating peripheral artery disease (PAD). It can be used to help in delivering guidewires and for channeling solutions and diagnostic agents.

Terumo is looking to purchase a portion Abbott Laboratories’ medical device business Buying Abbott’s medical device business could help Terumo expand its global footprint while offer abbott  some cash  as Abbott is working on consolidating after its $25 billion purchase of St. Jude

FDA approves Medtronic’s ‘artificial pancreas,’ the world’s first The MiniMed 670G hybrid closed-loop system is the first FDA-approved device that continuously measures glucose levels and delivers the appropriate dose of basal insulin, according to an FDA statement. It is indicated for people aged 14 or older with Type 1 diabetes and is intended to regulate insulin levels with “little to no input” from the patient

The FDA cleared Medtronic’s StealthStation software to help in the planning and placement of leads for deep brain stimulation In Medtronic’s deep brain stimulation therapy, a small neurostimulator is implanted under the skin of the chest. The stimulation is delivered via leads that are implanted in the brain and connected to the implant. A clinician uses an external programmer to set and adjust the stimulation.

Hill-Rom acquired  Tridien Medical,Hill-Rom subsidiary Comfort Holdings has acquired all outstanding shares of Tridien Medical, which makes patient positioning devices and support surfaces. The deal will help Hill-Rom reduce costs and improve margins,

Becton Dickinson will invest $100 million in its Holdrege, NE-based facility to expand its capacity for insulin syringe manufacturing.BD already makes more than 2 billion insulin syringes each year, and started operations at Holdrege in a 12,000-square-foot space. In the 50 years since, the facility has grown to 350,000 square feet and manufactures 20 different products. The new investment will go toward new tech and manufacturing equipment,

Zimmer Biomet launched a new total knee implant, the first of its kind to incorporate two polyethylene bearings on the medial and lateral sides of the device rather than just one polyethylene piece between the metal components of the implant.