• Medtronic's Endurant II Stent Graft Wins Expanded CE Mark Indication

    Medtronic announces its Endurant II/IIs Stent Graft System has earned CE Mark for an expanded indication. The regulatory win gives abdominal aortic aneurysm patients with short aortic necks an "off-the-shelf" option for endovascular aneurysm repair.Marie ThibaultPatients who have abdominal aortic aneurysms (AAA) with complex anatomies can now undergo endovascular aneurysm repair with a ready-made device option. Medtronic’s Endurant II/IIs stent graft system, used in endovascular aneurysm...
  • European Researchers Hack ICDs With Primitive Means

    The researchers warn medtech manufacturers that proprietary “security-by-obscurity” methods just won’t do.Nancy CrottiAn international research team says it has found that 10 different types of implantable medical devices, including the latest pacemakers and cardioverter defibrillators, are vulnerable to hacking.The team from KU Leuven University, Belgium, and England’s University of Birmingham used a “black-box” reverse-engineering approach and inexpensive off-the-shelf equipment to hack...
  • Device Company CEO Gets Prison Sentence

    A medical device CEO is sentenced to one year in prison for tax evasion.Marie ThibaultBriant Benson, president and CEO of multiple medical device companies including Woodland, CA-based Bentec Medical, was recently sentenced to 12 months and one day in prison for tax evasion. According to a December 2 news release from the U.S. Attorney's Office for the Eastern District of California, Benson did not file tax returns or pay income tax to the IRS from 2004 to 2006, even though he earned an...
  • Boston Scientific Buys Neovasc Tissue Processing Capabilities

    Boston Scientific picks up Neovasc's tissue processing technology and facility, an acquisition intended to support the manufacture of the Lotus transcatheter aortic valve.Marie ThibaultBoston Scientific announced a $75 million cash deal that includes Neovasc's tissue processing and manufacturing capabilities as well as a 15% equity interest in the Canadian cardiovascular company. Boston Scientific has agreed to pay approximately $67.9 million for Neovasc's tissue processing technology and...
  • Apple Has Been in Touch with FDA—a Lot and in Private

    A published report indicates the agency’s involvement in the development of Apple healthcare products and its efforts to keep the discussions secret.Nancy CrottiApple has shared numerous confidential emails and in-person meetings with FDA over the past three years to discuss an app that would help diagnose Parkinson’s disease and two separate but related cardiac devices, according to a report by MobiHealthNews.The news site filed a Freedom of Information Act request with FDA asking for...
  • How a Medical Device Prototype Ended Up in the Smithsonian

    The National Museum of American History added the first robotic medical device into its collection this month with the induction of the Robodoc, the world’s first active robotic surgical system.  Kristopher SturgisThe Smithsonian’s National Museum of American History announced this month the acquisition of the Robodoc, a 1989 prototype that went on to become a groundbreaking orthopedic surgical device for hip and knee replacement surgeries. The device, created by THINK Surgical...
  • Medtronic Launches CoreValve Evolut R in Japan

    Medtronic has gained reimbursement approval for its CoreValve Evolut R transcatheter aortic valve in Japan and is now launching the device, making it the first recapturable TAVR system in the country.Marie ThibaultThe Japanese Ministry of Health, Labor, and Welfare (MHLW) just granted reimbursement approval for Medtronic's CoreValve Evolut R, and the company is launching the transcatheter aortic valve (TAVI) in the country. The launch will mean the TAVR...
  • New Surgical Robot Offers Millimeter-Scale Precision

    The robot, known as Axsis, is one of the world's smallest known robots designed for surgical use and could offer a glimpse into the future of surgical robotic technologies.Kristopher SturgisEngineers from Cambridge Consultants, a product design and development firm out of the UK, announced this week the arrival of Axsis — a new miniature robotic tool designed to provide increased precision, access, and navigation for a variety of different clinical procedures that current surgical robots...
  • Trump Effect Could Dampen December M&A Mania in Medtech

    Looking forward to tax breaks promised by the incoming administration, device companies may put off plans to consolidate until next year.Nancy CrottiAs 2016 winds down, the traditional M&A madness that occurs in the month of December may not happen, as companies await tax breaks and other benefits from the incoming administration of president-elect Donald J. Trump.Not that 2016 needs the boost. While nothing rivaled Medtronic’s nearly $50 billion acquisition of Covidien in 2015, this year...
  • BD Closing North Carolina Medtech Tubing Plant

    About 120 workers will lose their jobs.Chris NewmarkerBecton, Dickinson and Co. says it will close its Creedmoor, NC, facility, which makes medical device tubing.Franklin Lake, NJ–based BD confirmed its plans to The News & Observer of Raleigh, NC, on Tuesday. Qmed could not immediately reach BD spokespeople for comment.The roughly 120 workers affected will be laid off over 12 months ending March 2018, with the assembly work going to Mexican plants and the molding going to BD’s Sandy,...
  • Trump Taps HHS, CMS Heads

    President-elect Trump has nominated Rep. Tom Price to be secretary of Health and Human Services and Seema Verma to head CMS. Here's what to know about the nominees.Marie ThibaultPresident-elect Donald Trump has nominated two people, well-known in the world of healthcare legislation, to head the Department of Health and Human Services and CMS. Trump tapped Representative Tom Price, MD (R-GA) for HHS Secretary and national health policy consultant Seema Verma, MPH for CMS administrator....
  • 21st Century Cures Act: What's in It for Medtech?

    Patient advocates love it, public-health groups hate it, and Senator Elizabeth Warren says it has been "hijacked." But what might the 21st Century Cures Act mean for medtech?Nancy CrottiWith the 21st Century Cures Act coming up for a vote in the U.S. House of Representatives today, the medtech industry could get some long-hoped for benefits.It’s been a long wait. The House passed its own version of the bill last year, but Senate Republicans wrangled with Democrats over the final language for...
  • Rupert Murdoch, Other Big Names Invested in Theranos

    The beleaguered blood-testing company is also facing a fresh lawsuit from investors.Jamie HartfordAustralian media mogul Rupert Murdoch and other well-known investors are among those who pumped millions of dollars into Theranos before problems with its blood-testing technology came to light, according to the Wall Street Journal (WSJ). Now, they could lose everything they put in.Stay on top of the latest trends in connected health by attending the BIOMEDevice San Jose conference, December 7–8,...
  • Medical Imaging, Powered by IBM

    IBM Watson Health and Merge Healthcare are bringing new insights, made possible through artificial intelligence and cognitive computing, to medical imaging.Marie ThibaultDr. Tanveer Syeda-Mahmood developed a tool that uses IBM Watson Health technology to help clinicians detect heart disease. Syeda-Mahmood is an IBM Fellow and chief scientist of the Medical Sieve Radiology Grand Challenge Project at IBM Research.Radiologists are about to get some help with their imaging workload.IBM...
  • How Philips Is Seeking to Make Radiology Smarter

    Officials at the Dutch multinational boast that they are the first to bring adaptive intelligence to radiology. Chris Newmarker Philips's new llumeo imaging and informatics technology uses adaptive intelligence to make it easier for radiologists to work with medical images.Philips announced Illumeo's introduction on Sunday. It integrates with existing systems including Philips IntelliSpace PACS.The intelligent software is but the latest example of "smart" imaging technology that has the...
  • Edwards Bolsters Mitral and Tricuspid Valve Offering with Valtech Cardio Buy

    Edwards Lifesciences announced an agreement to acquire Valtech Cardio Ltd., maker of a system for transcatheter repair of mitral and tricuspid valves, for $340 million plus potential milestone payments.Marie ThibaultTranscatheter heart valve giant Edwards Lifesciences has chosen to boost its transcatheter mitral and tricuspid valve repair portfolio. The company announced November 28 that it has agreed to acquire Israeli company Valtech Cardio Ltd. for $340 million with the...
  • This Hydrogel Could Stop Uncontrolled Blood Vessel Bleeding

    The research team that developed the catheter- and needle-delivered hydrogel say they've achieved proof of concept, as well as success in studies with animals.Chris NewmarkerA new shear-controlled hydrogel has shown promise when it comes to blocking blood vessels in hard to reach places, according to a researchers at Harvard University's Wyss Institute, MIT, Brigham and Women’s Hospital, and the Mayo Clinic. "It completely blocks vessels in situations where other...
  • Boston Sci Sensor System Predicts Heart Failure

    HeartLogic can detect when a patient’s condition worsens, according to a new study.Nancy CrottiA suite of sensors loaded via software to an implanted defibrillator can predict heart failure by up to a month, according to a study by an international team of researchers.The team set out to investigate whether Boston Scientific’s HeartLogic implantable defibrillators already used in heart failure patients could be retrofitted with sensors to track their conditions. They uploaded software to each...
  • OTC Sleep Apnea Device Approved in Europe

    A new anti-snoring and sleep apnea device known as the SnooZeal received approval in the EU this month. It’s touted as the first over-the-counter device that targets the root causes of snoring and sleep apnea.Kristopher SturgisEU markets are preparing for the commercial launch of a new anti-snoring and sleep apnea device known as the SnooZeal, a device that takes a new approach to sleep apnea and snoring through a daytime treatment method. The device secured a CE mark this month, making it the...
  • Boston Sci Closes on $210 Million Acquisition

    The EndoChoice Holdings purchase represents an expansion of Boston Sci's successful endoscopy business.Chris NewmarkerEndoChoice's Full Spectrum Endoscopy (FUSE) colonoscope (Image courtesy of EndoChoice)Boston Scientific on Tuesday announced the closing of its roughly $210 million purchase of EndoChoice Holdings.Based near Atlanta, EndoChoice has had $75 million in annual revenue, with products that include endoscopic imaging systems, devices, and infection control...