MedTech News
.................... by Andrew Celentano
Restore Medical wins FDA breakthrough nod for heart failure treatment device
Restore Medical announced today that it received FDA breakthrough device designation for its ContraBand heart failure treatment device.
Imperative Care wins FDA nod for stroke catheter
Imperative Care announced today that the FDA granted 510(k) clearance for its Zoom 6F insert catheters for ischemic stroke procedures.
FDA clears Hyperfine AI-powered brain imaging software
Hyperfine (Nasdaq:HYPR) announced today that the FDA cleared its ninth-generation AI-powered Swoop system software.
First health care device powered by body heat made possible by liquid based metals
In the age of technology everywhere, we are all too familiar with the inconvenience of a dead battery. But for those relying on a wearable health care device to monitor glucose, reduce tremors, or even track heart function, taking time to recharge can pose a big risk.
Smith+Nephew wins FDA nod for hip system compatible with Cori surgical robot
Smith+Nephew (NYSE: SNN)+
announced today that it received FDA 510(k) clearance for its new Catalystem primary hip system.
Philips wins FDA clearance for next-gen digital pathology system
Philips (NYSE: PHG)+
announced today that it received FDA clearance for its latest pathology solution, the IntelliSite Pathology Solution 5.1.
FDA clears Oticon Medical’s hearing loss implant
Oticon Medical announced today that the FDA granted clearance for its Sentio transcutaneous bone conduction hearing system.
Inspira™ Receives Israeli Regulatory Approval for the INSPIRA™ ART100 System
RA’ANANA, Israel, July 11, 2024 /PRNewswire/ — Inspira™ Technologies OXY B.H.N. Ltd. (Nasdaq: IINN) (Nasdaq: IINNW) (the “Company” or “Inspira”), a breakthrough medical technology company, is excited to announce the receipt of the Israeli Ministry of Health’s medical devices and accessories (“AMAR”) approval for the INSPIRA™ ART100, an Extra-Corporeal Membrane Oxygenation and Cardiopulmonary Bypass system. This is a pivotal milestone in Inspira’s strategy to conduct business development activities to bring its innovative products and technologies to the market.