• 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...
  • IBM Watson Health’s Dramatic Expansion

    Cognitive computing powerhouse IBM Watson Health is adding novel offerings and entering new agreements in an array of healthcare arenas.Marie ThibaultThis week, IBM Watson Health announced a slew of solutions and partnerships aimed at improving healthcare decision making and delivery. The announcement, which was released during a major gathering for the health IT community—the annual Healthcare Information and Management Systems Society (HIMSS) conference—covers offerings focused on value-...
  • How Edwards Is Getting Its Groove Back With CardiAQ

    After a three-week enrollment pause for additional design validation testing, Edwards Lifesciences is ready to get its CardiAQ transcatheter mitral valve replacement (TMVR) program back on track. But the path forward could still be a long one for TMVR in general, according to one medtech analyst. Amanda PedersenThe Edwards CardiaAQ transcatheter mitral valve is ready for clinical trials following the company's voluntary enrollment pause, during which it completed additional...
  • U.S. Panel Supports Use of CRISPR to Genetically Modify Human Embryos

    The National Academy of Sciences has become the first major institution to endorse the use of gene-editing technology in human embryos to prevent the birth of children with serious diseases.Kristopher SturgisA diagram of the CRISPR prokaryotic viral defense mechanism.The National Academy of Sciences, one of the nation’s most influential science advisory groups, announced its support for the use of CRISPR to modify human embryos in a series of heritable germline genome editing trials. The...
  • IBM Watson Health’s Dramatic Expansion

    Cognitive computing powerhouse IBM Watson Health is adding novel offerings and entering new agreements in an array of healthcare arenas.Marie ThibaultThis week, IBM Watson Health announced a slew of solutions and partnerships aimed at improving healthcare decision making and delivery. The announcement, which was released during a major gathering for the health IT community—the annual Healthcare Information and Management Systems Society (HIMSS) conference—covers offerings focused on value-based...
  • New Magnetic Implant Offers Controlled Drug Delivery

    Canadian researchers have created a new implantable device that can be triggered to release drugs by passing a magnet over the device outside the skin. Kristopher SturgisShown is an image of the magnetic implant next to the Canadianone-dollar coin. A new implantable drug delivery device was revealed last week by researchers from the University of British Columbia that could be used as an alternative for patients who rely on a high number of pills or intravenous injections for...
  • How A New AI Diabetes System Outperformed Top Docs

    Aspire Ventures pitted its adaptive artificial intelligence platform, A2I, against some of Europe's best diabetes specialists in an observational trial and the A2I won.Amanda Pedersen  A diabetes management system built on a new artificial intelligence platform proved it could offer people with diabetes a less invasive and more personalized solution for managing their blood glucose levels.Diabeter, a Netherlands-based diabetes clinic and research center that Medtronic bought in...
  • 3 Must-Have Features for Mobile Medical Devices

    Are your devices tough enough?Daphne AllenThere’s a trend toward mobile medical equipment today, observes Josh Blackmore, Global Healthcare Manager at RTP Company. “People are bringing medical technology to the patient,” he told Qmed at MD&M West. “Why move a sick patient?”Mobile equipment for ultrasound and x-ray procedures is being developed, as are mobile pharmacies and other devices, Blackmore noted. “There’s definitely a trend toward putting equipment on wheels,” he added. Such...
  • Is Integra's J&J Deal Risky Business?

    Integra Lifesciences made a $1.05 billion offer for Johnson & Johnson’s Codman Neurosurgery business, but some analysts see it as a risky move.Amanda Pedersen Valentine’s Day may have just been one day, but medtech has been showing the love all week long — for deals, that is.Integra Lifesciences Holdings Corp. was the third company in as many days this week to announce a billion-dollar acquisition. The company said it plans to pay Johnson & Johnson about $1.05 billion in cash for...
  • High Failure Rate Forces Zimmer Biomet To Recall Shoulders

    FDA said a shoulder replacement device recalled by Zimmer Biomet is considered a Class I recall. The device is being recalled due to a high rate of fractures. Amanda PedersenZimmer Biomet recalled its Comprehensive Reverse Shoulder device due to a high rate of fractures. FDA identified the recall Thursday as a Class I, the most serious type of recall. A high fracture rate forced Zimmer Biomet to recall its 3,662 of its Comprehensive Reverse Shoulder devices, and FDA classified...
  • Why Hologic’s Big Deal Threw Investors For A Loop

    Analysts were caught off guard by Hologic’s $1.65 billion proposal to buy aesthetic company Cynosure. Amanda Pedersen  Hologic Inc. threw analysts and investors for a loop this week with its $1.65 billion proposal to buy aesthetic technology maker Cyosure Inc., a deal that would place Hologic in a new, albeit fast-growing cash-pay segment.If all goes according to plan, the acquisition will close in April. At $66 a share, the deal has an equity value of about $1.65 billion and an...