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 […]
MassDevice Article Archive
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 […]
FDA clears on-device triage algorithms for critical care from GE HealthCare
GE HealthCare announced today that the FDA granted 510(k) clearance to its Critical Care Suite 2.1 with a pneumothorax (PTX) algorithm. The industry-first clearance allows the suite to detect, notify and triage the diagnosis of PTX. Chicago-based GE HealthCare’s updated algorithm expands the suite’s on-device triage capabilities, according to a news release. It provides immediate […]
Novosound expands wearable ultrasound operations in U.S.
Novosound announced today that it expanded its healthcare and wireless wearable ultrasound operations in the U.S. Glasgow, Scotland-based Novosound develops proprietary flexible thin-film ultrasound technology for medical imaging. The venture-backed company currently targets next-generation intravascular ultrasound (IVUS) imaging. The startup entered into a wearable ultrasound collaboration with Dr. Todd K. Rosengart, a leading U.S. cardiovascular […]
ReWalk Robotics demonstrates proof-of-concept with next-gen, AI-powered exoskeleton
ReWalk Robotics (Nasdaq:RWLK) announced today that it successfully demonstrated proof-of-concept with its next-generation exoskeleton. The Israel-based company, which operates out of Marlborough, Massachusetts, in the U.S., incorporated AI into its latest technology. It integrated advanced sensing technologies and AI to enable autonomous decision-making in the new exoskeleton prototype. ReWalk hit this milestone as part of […]
First cases performed in Kentucky with Stereotaxis robotic magnetic navigation system
Stereotaxis (NYSE:STXS) announced today that a health provider in Kentucky performed the first patients with its Genesis surgical robotic system. Physicians at Baptist Health Lexington successfully treated patients using the newest Stereotaxis advancement, the Genesis robotic magnetic navigation (RMN) system. Electrophysiologists at the same institution became the first to use RMN to treat patients all […]
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. […]
1nhaler raises $2.5M for sustainable single-use inhaler
1nhaler announced today that it raised $2.5 million (£2 million) to develop a sustainable single-use dry powder inhaler. The Scotland-based drug delivery device developer cited limited inhalable medicine development due to a number of reasons. Those include accessibility, cost, performance and environmental impact. Its own development could enable the delivery of several dry powder drugs […]
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, […]
