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, August 16, 2023. Fast Five by MassDevice · Philips has another serious recall, Microbot Medical inks surgical robot manufacturing deal People living with diabetes are […]
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FDA grants de novo nod to hypertrophic cardiomyopathy AI algorithm from Viz.ai
Viz.ai announced today that the FDA granted de novo approval to its Viz HCM module for detecting hypertrophic cardiomyopathy. San Francisco-based Viz.ai says this creates a new regulatory category for cardiovascular machine learning-based notification software. The company supports its algorithm’s deployment through a multi-year agreement with Bristol Myers Squibb. They struck that partnership deal in […]
Microbot Medical inks deal to expand surgical robot manufacturing capabilities
Microbot Medical (Nasdaq:MBOT) announcd today that it signed a manufacturing agreement with B.Y. Medimor for its surgical robot. Braintree, Massachusetts–based Microbot develops the Liberty single-use endovascular robotic surgical system. It designed Liberty for use in neurovascular, cardiovascular and peripheral vascular procedures. The system includes a compact design and remote operating capabilities to reduce radiation exposure […]
Philips Respironics has a Class I level ventilators recall
The FDA has posted information on its website about another serious recall involving Philips Respironics products. The news comes the same week that Philips got a vote of confidence from Exor, the investment arm of Italy’s wealthy Agnelli family, which bought a 15% stake in the Dutch medtech giant to become its largest shareholder. Media […]
Fast Five: Getinge has another Class I recall, Asensus aims for 2025 FDA clearance for Luna surgical robot
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, August 14, 2023. Fast Five by MassDevice · Getinge has another Class I recall, Asensus aims for 2025 FDA clearance for Luna surgical robot Artificial […]
Illumina says SEC is investigating Grail acquisition
Add a U.S. Securities and Exchange Commission investigation to the list of problems that Illumina has faced since it acquired Grail for $8 billion in 2021. Illumina disclosed the investigation in its 10-Q filed with the SEC on Aug. 10: “In July 2023, we were informed that the staff of the SEC was conducting an […]
Siemens Healthineers, SSM ink deal to improve health equity
SSM Health and Siemens Healthineers announced today that they entered into a 10-year strategic partnership focused on health equity. The companies aim to expand access to high-quality care and aid in training the next generation of healthcare workers. Siemens Healthineers says the agreement marks its largest geographic strategic partnership to date. SSM Health, a fully […]
FDA clears wireless patient deterioration monitoring system from GE HealthCare
GE HealthCare announced today that it received FDA 510(k) clearance for its Portrait Mobile wireless and wearable monitoring solution. Portrait Mobile enables real-time continuous monitoring with a personalized view of a patient’s vitals. It also keeps patients mobile during critical recovery periods, including after surgery or ICU discharge. According to GE HealthCare, continuous monitoring and […]
Asensus Surgical targets FDA clearance for Luna surgical robot in 2025
Asensus Surgical (NYSE:ASXC) announced its second-quarter financial results and shared an update on its Luna surgical robot platform. Shares of ASXC rose 9.8% at 36¢ apiece in late-afternoon trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — stayed even. Research Triangle Park, North Carolina-based Asensus unveiled […]
Shockwave Medical increases offering price to $650M
One day after proposing a private offering worth proceeds of $500 million, Shockwave Medical announced a price increase for that offering. The Santa Clara, California-based calcified cardiovascular disease treatment developer announced its private offering yesterday, Aug. 10. That announcement covered convertible senior notes due in 2028. It featured an additional option to purchase, within 13 […]
Fast Five: Shockwave Medical to raise $500M, ZimVie has an updated spin implant set to launch this fall
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, August 11, 2023. Fast Five by MassDevice · Shockwave Medical to raise $500M, ZimVie has an updated spin implant set to launch this fall In […]