• FDA Warns Against TVAM Using Balloon Angioplasty Devices

    FDA issued a warning to patients and physicians against an experimental procedure called transvascular autonomic modulation (TVAM) using balloon angioplasty devices. The agency said TVAM puts patients at risk for several reasons.Amanda Pedersen Patients and doctors considering an experimental procedure called transvascular autonomic modulation (TVAM) for the treatment of autonomic dysfunction such as Parkinson's disease, MS, or fibromyalgia, among others, should really do their homework....
  • Smart Clothing Could Be Coming to Your Closet

    Forget accessories like smart watches. The next wave of wearable technology will be part of your wardrobe.Jamie HartfordKiourti's research has led to woven circuits that are as precise astraditional PCBs.Wearable form factors have been touted as a way to improve the stickiness of medical technologies, but even strapping on a fitness tracker or smart watch is an extra step that users may decide to skip. Thanks to new research, complying with therapy could soon be as easy as getting dressed in...
  • BIOMEDevice Boston 2017 Innovation Prize Official Rules

    NO PURCHASE OR PAYMENT OF ANY KIND IS NECESSARY TO ENTER OR WIN. A PURCHASE OR PAYMENT WILL NOT IMPROVE YOUR CHANCES OF WINNING. CONTEST IS VALID ONLY IN THE UNITED STATES (EXCLUDING PUERTO RICO) AND CANADA (EXCLUDING QUEBEC) – ENTRIES FROM PERSONS LIVING IN OTHER COUNTRIES WILL BE AUTOMATICALLY DISQUALIFIED. GENERAL CONDITIONS:The BIOMEDevice Boston Innovation Prize (the “Contest”) is sponsored by UBM LLC, 2901 28th St., Ste. 100, Santa Monica, CA 90405 (“UBM” or...
  • Ding Dong the Device Tax is (Almost) Dead

    GOP healthcare bill would permanently do away with the 2.3% medical device tax. AdvaMed and other industry trade groups have been strongly pushing for a permanent repeal of the device tax for months.Amanda Pedersen Republican lawmakers this week unveiled a plan that would dismantle key aspects of Obamacare and, so far, the bill has drawn wildly mixed reactions. In short, President Donald Trump loves it, conservatives and democrats hate it (albeit for very different reasons), and opinions...
  • Call for Entries: BIOMEDevice Boston 2017 Medtech Innovation Prize

    If you'll be showcasing an innovative medtech product or service at the upcoming BIOMEDevice Boston Expo May 3–4, enter our contest for a chance to be included in a special innovation tour for attendees. Entries are due March 31, 2017.UBM is looking to identify the most innovative exhibitors at BIOMEDevice Boston and give them the recognition they deserve. The BIOMEDevice Boston Innovation Prize is a contest acknowledging the most innovative products, services, and technologies developed...
  • Why Edwards-Bos Sci Battle is Far from Over

    A UK patent court issued a split decision in a case between Edwards Lifesciences and Boston Scientific, but the battle over the two companies’ transcatheter heart valve patents is far from over, and could ultimately settle in a cross-licensing agreement.Amanda Pedersen A UK patent court ruled that one of Boston Scientific’s patents related to outer seals for transcatheter heart valves, which was asserted against Edwards’ Sapien 3 valve, is invalid, but that a second patent is valid and...
  • Non-Phthalate Plasticizer Performs Comparably in Blood Bag Study

    Non-phthalate plasticizer suggested as a potential alternative to DEHP.By Daphne AllenA recent study demonstrates that a non-phthalate plasticizer performs comparably to a phthalate plasticizer when used in red blood cell storage bags. The non-phthalate plasticizer, Eastman 168 SG, was studied at the Blood Center of Wisconsin, reported Mark Brucks, market development manager, plasticizers, for Eastman.Consisting of DEHT (Bis (2-Ethylhexyl) Terephthalate), Eastman’s “sensitive grade” non-...
  • Emerging-Market Companies Set to Rise in Medtech

    You’ve heard about the rise of the emerging markets in the medical device industry, but this time, there’s a new twist on the trend.Marie ThibaultThe promise and rapid growth of healthcare in the emerging markets is old news by now. The potential of the medical device industry in emerging markets is often touted by large multinational companies that have meaningful presences in both developed and developing countries.That dynamic is starting to change, according to the findings of a new report...
  • How Abbott Is Gaining New ‘FlexAbility’ in Arrhythmia Market

    FDA approved Abbott’s FlexAbility sensor-enabled ablation catheter for atrial flutter. The device is among the many gems the company picked up in its $25 billion acquisition of St. Jude Medical. Amanda PedersenAbbott's FlexAbility ablation catheter is the second Sensor Enabled tool developed for the EnSite Precision cardiac mapping system. Abbott’s $25 billion acquisition of St. Jude Medical boosted the company’s status in the electrophysiology market. Among the many technology gems...
  • Could Exact Sciences Help Reverse This Troubling Cancer Trend?

    With colorectal cancer on the rise in young adults, the maker of the Cologuard noninvasive home test for the disease says it might be time to adjust the screening age.Nancy CrottiColorectal cancer is on the rise in young adults, according to a study by the American Cancer Society, which is recommending more screenings. That might represent an opportunity for a company that markets an alternative to the colonoscopy.Don't miss the BIOMEDevice Boston Conference and Expo, May 3–4, 2017.Exact...
  • Debris-Catching Device for TAVR Wins Over FDA Panel

    An FDA advisory panel recently recommended approval for Claret Medical's Sentinel Cerebral Protection System based on a lack of alternative options and a low safety risk, but questions remain about the clinical efficacy of the device. As a de novo application, the Sentinel did not require a formal panel vote.Amanda PedersenClaret Medical's Sentinel Cerebral Protection System got a green light from an FDA panel for use during TAVR procedures. The company now expects the device to be on the U.S....
  • Alere Has 99 Problems And Asia's Just One

    Alere Inc. said it will file its annual report late again this year as the company tries to sort out an accounting mess in Asia. Amanda Pedersen Alere Inc. can't seem to catch a break. The company filed for a 15-day extension for its annual report because it is trying to sort out inappropriate conduct at a subsidiary in South Korea that could shift the timing of some revenue transactions in 2013, 2014, 2015, and the first three quarters of 2016.Keep track of who's buying, selling, and...
  • How A New Blood Test Could Forecast Heart Attacks

    Data published in the Journal of the American College of Cardiology shows a new blood test detected a significant coronary obstruction 90% of the time, and also tipped doctors off to a patient's risk of a future heart attack.Amanda Pedersen A Massachusetts General Hospital cardiologist said Prevencio Inc.'s multi-protein blood test could represent a new standard of care for diagnosing heart disease and predicting heart attack risk.  A new blood test could change the way doctors...
  • Updated Blood Collection Device Draws 510(k) from FDA

    FDA cleared Velano Vascular's PIVO needle-free blood collection device, which attaches to a peripheral IV system. Nancy CrottiThe PIVO advances an inner tube via a slider mechanism through the peripheral IV catheter system. Velano Vascular has won 510(k) clearance for a next-generation version its blood-draw device aimed at reducing painful needle sticks.The PIVO, formerly called TIVA, is a  single-use, needle-free blood collection device that attaches to a peripheral IV system....
  • Medtronic Solitaire Passes Muster In The Real World

    Real-world experience with Medtronic's Solitaire stent retriever in patients suffering acute ischemic stroke shows the device can perform just as well in the real world as it did in four separate clinical trials.Amanda PedersenRegistry data presented at the International Stroke Conference showed Medtronic's Solitaire stent retriever performed as well in real-world clinical settings as it did in four separate randomized controlled trials. No matter how well a device performs in clinical...
  • How a Brain Implant Helped Three People Text

    Stanford engineers and neurosurgeons have developed a new experimental brain-controlled technology designed to help paralyzed patients channel thoughts into movement and speech.Kristopher SturgisStanford's Jaimie Henderson and Krishna Shenoy are part of a consortium working on an investigational brain-to-computer hookup. A project nearly 15 years in the making is beginning to come to fruition for a group of Stanford researchers who have been working tirelessly to create a new brain-...
  • Shareholders Punish Boston Scientific For Latest Lotus Recall

    Boston Scientific pulled all of its Lotus valves from the market based on reports of a mechanical mishap with a pin connecting the valve to the delivery system. The recall could delay the U.S. launch of the Lotus Edge valve by about six months.Amanda PedersenBoston Scientific's latest Lotus problem could delay the U.S. launch of Lotus Edge by about six months Shareholders didn't hold back on punishing Boston Scientific after the company removed all Lotus valves from the market after...
  • Siemens Launches Digital Health Ecosystem

    Siemens Healthineers has established a global digital ecosystem aimed at connecting healthcare providers with companies that provide heatlhcare services and solutions. The company has already recruited several partners to the ecosystem.Amanda Pedersen  There is a lot of uncertainty in healthcare today, especially in the United States where federal lawmakers are in the process of repealing and replacing the Affordable Care Act otherwise known as Obamacare. But the shift toward...
  • How Medtronic Built A Smarter Stapler

    Medtronic's new Signia stapling system is designed with a built-in smart technology to detect the variability of tissue thickness and automatically adjust the stapler's speed during surgery. The goal is to help surgeons fire staples consistently and evenly.Amanda Pedersen The handle of Medtronic's Signia stapler includes an LED screen that provides real-time feedback during surgery.  Medtronic wants you to have a smarter stapler. The Dublin-based company launched a new kind...
  • Cell-Infused Wearable Sensors Aim to Detect Infection and Disease

    A new "living material" is designed with live cells that can be genetically programmed to light up in the presence of certain chemicals, bacteria, and possibly even biomarkers for disease. Kristopher SturgisShown are the cell-infused sensors in glove and bandage form.A group of engineers and biologists from MIT announced this week the design of a new wearable material infused with live cells that can be genetically programmed to light up and glow when the cells come into contact with...