Boston Scientific Corp. reported positive results for its Emblem subcutaneous implantable defibrillator (S-ICD) system and next-generation Watchman Flx left atrial appendage closure (LAAC) device at the Heart Rhythm Society scientific sessions, which were online only this year due to the COVID-19 pandemic. Read More
The U.S. FDA’s enforcement regarding products related to the COVID-19 pandemic has picked up steam recently, but the U.S. Federal trade commission (FTC) is also involved in this enforcement arena. Leonard Gordon, a partner at Venable LLP’s New York office, told BioWorld that while the FTC and FDA missions seem to overlap, the FTC primarily targets unsupportable advertising claims rather than product labeling, a particularly relevant area in the COVID-19 pandemic. Read More
Denver-based Biointellisense Inc. has unveiled Biobutton, a coin-sized, disposable medical device that measures continuous temperature and other vital signs for 90 days. The device, coupled with HIPAA-compliant data services, permits remote data capture and continuous multiparameter monitoring of temperature, respiratory rate and heart rate at rest, body position, sleep and activity state. Read More
LONDON – A new technique for analyzing solid tumor DNA has been shown to significantly improve scoring of mutation burden, making it possible to identify patients who will respond to immunotherapy. Read More
Palo Alto, Calif.-based Limbix Health Inc. secured $9 million in series A funding for development of Spark, its prescription digital therapeutic (PDT) designed to treat depression in adolescents. GSR Ventures led the round with additional funding from other existing investors, including Sequoia Capital, Storm Ventures, Nextgen Venture Partners and Bixink Therapeutics. Read More
PERTH, Australia – As New Zealand and Australia prepare to open their economies, regulators in these two neighboring countries are taking very different approaches to regulating COVID-19 devices with New Zealand restricting point-of-care tests, while Australia imposes tougher postmarket activities. Read More
In the rush to develop a COVID-19 vaccine, integral parts of the equation are being overlooked in the U.S., according to a whistleblower complaint filed this week by Rick Bright over his removal as director of the Biomedical Advanced Research and Development Authority (BARDA). Even if millions of doses of vaccine are ready to go by January, as the NIH’s Anthony Fauci a few weeks ago said could happen, there may not be enough needles and syringes to deliver those doses. Read More
The challenges to deploy diagnostic and surveillance testing for the COVID-19 pandemic will persist at least until a vaccine is ready if not well beyond that milestone. In our series “Diagnosing the state of COVID-19 testing,” BioWorld MedTechexplores the complexities of developing accurate, properly regulated tests to help bring the world back online with confidence.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Atricure, Boston Scientific, Medtronic, Thermedical. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alpha Software, Aptar, Atrion, Beroni, Bioreference Laboratories, Cryolife, Fullerton Health, Guardant Health, Helius Medical Technologies, Livinguard, Opko Health, Orthofix, Twist Bioscience, United Health Products. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aidoc. Read More
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Bedfont Scientific, Philosys, Rutgers Clinical Genomics Laboratory, Spectrum Solutions, University of Kentucky. Read More
Keeping you up to date on recent developments in neurology, including: Focused ultrasound opens brain for gene therapy; Study links early sleep problems to autism diagnosis; New trial platform could accelerate finding a cure for Parkinson's disease. Read More
