• What Medtronic's Price-Fixing Fine Means for Other Medtech Companies in China

    A Chinese regulatory body levied a $17 million fine against Medtronic for setting low-end prices on certain devices, and officials said that could just be the "tip of the iceberg."Nancy Crotti A $17 million fine levied by the Chinese government against Medtronic PLC this week may signal a closer look at foreign medtech business dealings in general in that country.China’s National Development and Reform Commission (NDRC) fined Medtronic for refusing to allow the company’s dealers and...
  • Medtech Companies Take Note: Americans' Life Expectancy is Declining

    Although the cancer death rate declined, the mortality rate for Alzheimer's disease jumped significantly.Maureen KingsleyLife expectancy for the average American in 2015 declined by 0.1 year from 2014, the CDC’s National Center for Health Statistics (NCHS) reporrted in a data brief released this month. Life expectancy was 78.8 years at birth in 2015 and 78.9 years in 2014. For male Americans specifically, life expectancy decreased from 76.5 years in 2014 to 76.3 years in 2015, and for female...
  • Does Tort Reform Actually Stifle Medtech Innovation?

    New research shows that capping liability costs in medical malpractice cases may not spur medtech innovation across the board.Nancy Crotti High litigation costs dampen medtech innovation, and caps on monetary damages encourage it. That’s what the industry has been saying for decades, but it may not be entirely true.Learn what it takes to bring an innovative medical device to market at the MD&M West conference, February 7–9, 2016.U.S. and Canadian researchers have found that in...
  • Polymer Extruder Is Repeat Winner of Innovation Prize

    Attendees at BIOMEDevice San Jose selected Zeus's LCP monofilament as the winner of the Innovation Prize.Marie ThibaultThe Zeus LCP Monofilament, launched in September, was named the BIOMEDevice San Jose Innovation Prize winner during the event on December 7. This is the second Innovation Prize win for Orangeburg, SC-based Zeus—the LCP Monofilament also pulled down the MD&M Minneapolis Innovation Prize in September.Zeus introduced its LCP (liquid crystal polymer) Monofilament as a way to...
  • Abbott Moves to Ax Alere Deal

    Medtech giant Abbott Laboratories has made it official: It wants out of its nearly $6 billion bid for diagnostics company Alere Inc.Nancy CrottiIllinois-based Abbott, which sued Alere last month in Delaware Chancery Court for breach of contract, has filed an additional complaint seeking to terminate the $5.8 billion deal. In a statement, Abbott cited “numerous negative developments (that) are unprecedented and are not isolated incidents brought on by chance.“We have attempted to secure...
  • Seller of Fake 'Star Trek' Medical Devices Sentenced to Prison

    An Illinois conman was sentenced to five years in prison this week after being found guilty of selling fake Star Trek-inspired medical devices. Kristopher SturgisHoward Leventhal, a fraudster from Grayslake, IL, received a five-year prison sentence this week after a New York federal judge convicted Leventhal for conning investors with a healthcare device that he claimed would function like Dr. James McCoy’s tricorder device on Star Trek. The 60-year-old defendant made a last ditch appeal for...
  • FDA OKs Abiomed's Impella CP Heart Pump for High-Risk PCI

    The Impella CP heart pump, which already had FDA approval for use in cardiogenic shock patients, is now indicated for use in high-risk percutaneous coronary interventions.Marie ThibaultAbiomed announced its Impella CP heart pump now has FDA approval for a high-risk percutaneous coronary intervention (PCI) indication. The regulatory decision expands the device’s approved indications beyond use in patients with cardiogenic shock.The high-risk PCI indication allows Impella CP to be used...
  • Former Medtronic CEO Challenges Trump's Take on Offshoring Jobs

    Donald Trump won the U.S. presidential election in part by pushing the idea that moving jobs overseas is hurting Americans, but former Medtronic CEO William W. George says it's not that simple.Jamie HartfordLast week, president-elect Donald Trump made headlines when he forged a deal with Carrier to keep in Indiana 1000 jobs the manufacturer of air conditioning and refrigeration systems had previously planned to move outside of the United States. Many saw the announcement as Trump making good on...
  • Can This New Subscription Service Disrupt Diabetes Care?

    One Drop's new diabetes platform combines a design-forward blood glucose monitoring system with a live-support app and subscription service for supplies.Kristopher SturgisToday One Drop announced the official launch of its new subscription-based glucose monitoring system that brings together advanced medical technologies with mobile capabilities — all in an effort to provide advanced diabetes care that is both affordable and easily accessible. The technology provides an unlimited supply of...
  • 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...
  • 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...
  • 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...
  • 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...
  • 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 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...
  • 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 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....