BiVacor announced today that the FDA granted investigational device exemption (IDE) for its total artificial heart (BTAH). IDE approval allows BiVacor to begin its first-in-human early feasibility study (EFS) for the BTAH system. The Houston-based company aims to evaluate BTAH’s safety and feasibility as a bridge to a heart transplant for patients with biventricular heart […]
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FDA clears oral device for severe sleep apnea from Vivos Therapeutics
Vivos Therapeutics (Nasdaq:VVOS) announced today that the FDA cleared its removable CARE oral devices for treating severe obstructive sleep apnea (OSA). The CARE (complete airway repositioning and/or expansion) line includes the flagship DNA, mRNA and mmRNA oral appliances. Littleton, Colorado–based Vivos says its clearance makes it the first company bringing a clear alternative to CPAP […]
Fast Five: Henry Schein has more cybersecurity disruptions, Orthofix has a new CEO
Welcome to the MassDevice Fast Five medtech news podcast, the show that keeps you up-to-date on the latest breakthroughs in medical technology. Here’s what you need to know for today, November 29, 2023. Fast Five by MassDevice · Fast Five: Henry Schein has more cybersecurity disruptions, Orthofix has a new CEO Scottish startup 1nhaler raised […]
FDA warns of thermal issues with Philips DreamStation 2 CPAP machines
The FDA is warning patients and health care providers to watch Philips DreamStation 2 continuous positive airway pressure (CPAP) machines for signs of overheating. The medical device safety agency said it recently received an influx of medical device reports (MDRs) associated with thermal issues such as fire, smoke, burns, and other signs of overheating while […]
First patient enrolled in Penumbra study of computer-assisted vacuum thrombectomy
Penumbra (NYSE:PEN) today announced the first patient enrolled in STORM-PE, a trial of its Lightning Flash thrombectomy system. Lightning Flash, a mechanical thrombectomy system, received FDA clearance in January. The system features Penumbra’s novel Lightning intelligent aspiration technology with dual-clot detection algorithms. Combining it with innovative catheter engineering, Penumbra designed Lightning Flash to quickly remove […]
Orthofix has a new CEO
Orthofix Medical announced today that it named Massimo Calafiore as its new president and CEO. Lewisville, Texas-based Orthofix expects the appointment of Calafiore to go into effect in early 2024. He currently serves as CEO of LimaCorporate and will take over the corner office at Orthofix following the completion of Lima’s acquisition by Enovis. The […]
Fast Five: What’s next for Medtronic’s RDN program after FDA approval?
Welcome to the MassDevice Fast Five medtech news podcast, the show that keeps you up-to-date on the latest breakthroughs in medical technology. Here’s what you need to know for today, November 28, 2023. Fast Five by MassDevice · What’s next for Medtronic’s RDN program after FDA approval? Philips this week unveiled its next-generation ultrasound systems. […]
Henry Schein reports more disruption as cyberattackers take credit
Henry Schein said today that it is working to bring its ecommerce platform back up after more problems related to its cyberattack. The medical device manufacturer and distributor said last week that its ecommerce platform and other applications were unavailable and that “the threat actor from the previously disclosed cyber incident has claimed responsibility.” Today, […]
Cleveland Clinic, Canon plan a medical imaging research center
Cleveland Clinic and Canon today announced a strategic research partnership involving imaging and healthcare IT. The two organizations expect to establish a comprehensive imaging research center. The center will potentially include shared workspace in an existing building in Cleveland’s Fairfax neighborhood, adjacent to Cleveland Clinic’s main campus, according to a news release. A cross-institutional team […]
Medtronic launches left atrial appendage exclusion system
Medtronic announced today that it launched its Penditure left atrial appendage (LAA) exclusion system in the U.S. Penditure, an implantable chip, comes pre-loaded on a single-use delivery system for LAA management during concomitant cardiac surgery procedures. Medtronic designed it with a curve to better match atrial anatomy and without fabric for atraumatic closure and reduced […]
What’s next for Medtronic’s RDN program after FDA approval?
Medtronic is planning its first commercial renal denervation (RDN) cases and is already running a postmarket study after winning FDA approval of its Symplicity Spyral system for hypertension. In an interview before the Thanksgiving break, Medtronic SVP Jason Weidman — who’s also president of the company’s coronary and RDN business — said he expects the […]