• BIOMEDevice San Jose 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 San Jose Innovation Prize (the “Contest”) is sponsored by UBM LLC, 2901 28th St., Ste. 100, Santa Monica, CA 90405 (“UBM”...
  • St. Jude Medical Halts Nanostim Implants

    The company confirms lost telemetry and pacing output among a small portion of the leadless pacemakers implanted. Chris NewmarkerSt. Jude Medical's technical woes appear to be continuing, and this time they involve the company's Nanostim leadless pacemaker. The Little Canada, MN–based medical device company confirmed on Friday that it has halted implanting the pacemaker. There have been seven cases, 0.5% of the total, in which there was lost telemetry and pacing output; the...
  • How Batteries Create Better Computers on Wheels

    Power supply has been a major challenge when it comes to the computers-on-wheels that are rolled around hospitals and other healthcare settings.Daw Tsai, DT ResearchIt may seem strange, but batteries are taking a front row seat in the effort to improve point-of-care in hospitals, doctors' offices and other care facilities. Let me explain why.Over the past few years, healthcare professionals have found that having data access at the point-of-care can dramatically improve the overall efficiency,...
  • FDA May Get Tough on Adverse Event Reporting

    An inspection of 17 hospitals revealed they had not been reporting safety problems.Nancy CrottiFDA is inching closer to enforcing medtech adverse event reporting requirements, following inspections of 17 hospitals that failed to report events linked to power morcellators and contaminated duodenoscopes.The December 2015 inspections revealed that those hospitals, and probably many more, failed to train staff or even have procedures in place for reporting such events, writes Jeffrey Shuren, M.D.,...
  • 23andMe Giving Up on Next-Gen Sequencing

    CEO Anne Wojcicki describes it as a “hot shiny object” for her industry. But the company wants to focus on core areas for now. Chris Newmarker23andMe—which has made a name for itself selling relatively affordable genetic tests to the masses—has halted its pursuit to create more advanced sequencing technology meant to reveal so much more about our medical predispositions.Anne Wojcicki, the company’s CEO and co-founder, described the technology as a “hot shiny object,” but also one that is very...
  • Boston Scientific Beats Wall Street Expectations in Q3

    Recent acquisitions and positive clinical trial results could bode well for the future, too.  Qmed StaffBoston Scientific beat Wall Street’s expectations in the third quarter of 2016, growing organic revenue 9% thanks to strong performance in its cardiovascular and medsurg segments, as well as growth in international markets.Don't miss BIOMEDevice San Jose, December 7–8, 2016.Sales of the company’s cardiovascular products grew 12%, and CEO and chairman Michael Mahoney called out successful...
  • Edwards Q3 Earnings Disappoint

    Revenues fell short of analysts’ expectations, sending the company’s stock tumbling.Qmed StaffThe Sapien 3 is Edwards's third-generation TAVR device.Edwards Lifesciences's revenue fell short of expectations in the third quarter of 2016, and the disappointment sent the company's stock price down more than 17% the day after its earnings call.Don't miss BIOMEDevice San Jose, December 7–8, 2016.But, as one analyst mused on the call, Edwards appears to be a "victim of [its] own success"...
  • How Sensors Are Disrupting Surgical Tools and Diagnostics

    Hariharan Subramanian, vice president of research and development at Briteseed, previews his BIOMEDevice San Jose talk on advances in medical sensor technologies and how they’re forging the next generation of surgical tools and diagnostic devices. Kristopher SturgisBriteseed's SafeSnips puts low-cost optical sensor technology into the jaws ofsurgical dissectors and energy tools to provide real-time information to surgeons.  When it comes to developing next-generation medical...
  • J&J Caves to PETA Protest

     The company’s decision to stop using live animals in training videos comes after complaints by the animal-rights group.Nancy CrottiJohnson & Johnson has promised to stop using live animals in sales training videos for surgical device representatives.The company’s Ethicon unit had been depicting pigs that were killed in the videos, according to a reportby STAT. People for the Ethical Treatment of Animals (PETA) complained to J&J about the videos and publicized its concerns,...
  • First 3-D Heart-on-a-Chip Has Integrated Sensing

    Quickly fabricated and customized, it may eliminate the need for animal testing.Nancy CrottiHarvard University researchers have made what they are touting as the first entirely 3D-printed organ-on-a-chip with integrated sensing. By using new printable inks for multi-material 3-D printing, they were able to automate the fabrication process while increasing the complexity of the devices.This new approach to manufacturing addresses a couple of the major problems with current organ-on-a-chip...
  • AliveCor and Mayo Clinic Partner to Dig into ECG Data

    By applying machine learning to heart data, the digital health company and the nonprofit medical practice and research group hope to uncover new health indicators.Qmed Staff                     AliveCor makes the Kardia mobile ECG device.                              Digital health company AliveCor and Rochester, MN-based Mayo Clinic are teaming up to...
  • Muddy Waters Keeps Hammering St. Jude on Cybersecurity

    The investment firm says a third-party cybersecurity expert’s report backs up their claims that St. Jude Medical’s pacemakers and defibrillators are vulnerable to cyber attacks.Nancy CrottiThe investment and security firms that claim St. Jude Medical’s cardiac rhythm devices are vulnerable to cyberattack are claiming their actions are protected by the First Amendment.In their answer to St. Jude’s federal lawsuit, defendants Muddy Waters Capital, cybersecurity outfit MedSec, and three principals...
  • Is Abbott’s Acquisition of Alere Doomed?

    Federal investigations of Alere, a class-action complaint brought by its investors, and an accusation that Abbott bullied the company to accept a deal-termination offer may have soured the planned acquisition beyond repair.Maureen KingsleyDespite having won the approval of its shareholders last Friday, October 21, Waltham, MA-based Alere Inc.’s pending acquisition by healthcare giant Abbott Laboratories does not appear to be a sure thing. The deal, announced this past February, would have the...
  • Muddy Waters, MedSec Again Attack St. Jude Over Cybersecurity

    New videos purport to show how company programmers made it easy for hackers to attack cardiac implants and pacemakers.Nancy CrottiInvestment firm Muddy Waters and security research company MedSec have fired another salvo against St. Jude Medical in their battle over the alleged vulnerability of St. Jude’s implantable cardiac devices.The duo put up a video (see above) on the website Profits Over Patients, with ominous music playing while a middle-aged man in a darkened conference room talks...
  • Study: Reimbursement Model for Home Medical Equipment is ‘Unsustainable’

    The study, led by the American Association of Homecare, reveals that Medicare reimbursement rates cover less than 90% of the cost of home medical equipment.Maureen KingsleyIn the face of an aging population, baby boomers reaching eligibility age for Medicare, and a continuing cultural desire to spend senior years at home rather than in nursing facilities, a new study concluded that Medicare reimbursement rates for home medical equipment are inadequate.On average, the government program covers...
  • Could This Device Replace Drugs for Crohn's Treatment?

    SetPoint Medical’s vagus nerve stimulation implant has shown promise for treating the debilitating inflammatory bowel disease, according to a new European study.Nancy CrottiSetPoint Medical is also studying its implantable neuromodulation technology for treatment of rheumatoid arthritis. Image courtesy of SetPoint MedicalA European study using a bioelectronic device has shown positive results in treating Crohn’s Disease.The implant, made by SetPoint Medical of Valencia, CA, delivers timed,...
  • 5 Reasons Entrepreneurship in Medtech is Dying

    The number of medtech startups launched per year has declined by 70% since the late 1970s, according to a new report from AdvaMed.Medtech is sorely in need of newcomers. Around a third of the companies in the industry today have been doing business for 25 years or more, and over half have been around longer than 16 years, according to a new report from the trade association AdvaMed.The problem is a decrease in entrepreneurship. Almost 70% more startups were formed in 1978 than in 2015,...
  • New Biocompatible Optical Fibers Could Have Medtech Uses

    Harvard Medical School and MIT researchers have created a stretchy optical fiber made from hydrogel that can be implanted into the body to deliver therapeutic pulses of light—as well as light up to signal signs of disease.Kristopher SturgisA new biocompatible optical fiber made from hydrogels boasts highly stretchable properties, enabling it to bend and twist with the body upon implantation. The new technology is thought to have potential as a long-lasting implant that could be used...
  • How Bad Are FDA Device Reporting Loopholes?

    Loopholes in the way medical device manufacturers report adverse events to FDA allow manufacturers to keep critical details under wraps, according to a new report. Joyce LairdMedical device adverse event reports are far from timely in the United States, according to a recent report by Joe Carlson and Jim Spencer in the Star Tribune of Minneapolis.Medical devices makers are supposed to tell FDA whenever they learn that a product may have injured someone, and that those reports should be...
  • Using MRI to Image Patients for Stroke Risk

    Researchers at Northwestern University have developed a new imaging technique that can image blood flow in three spatial dimensions—helping to identify patients at risk for stroke.Kristopher SturgisNorthwestern University researchers have created a new imaging technique that could help doctors better predict which patients are most at risk for stroke by examining atrial fibrillation and blood flow. Michael Markl, professor of biomedical engineering at the Northwestern University Feinberg School...