MedTech News
CytexOrtho gets FDA approval for first-in-human trial of absorbable hip implants
CytexOrtho today said it has approval from the FDA to start a Phase 1 clinical trial evaluating the safety and efficacy of its absorbable hip implant in human patients.
FDA clears Paragonix KidneyVault portable renal perfusion system
Paragonix Technologies this week announced it received FDA 510(k) clearance for its KidneyVault donor kidney preservation system.
Insulet fully launches Omnipod 5 app for iPhone in U.S.
Insulet (Nasdaq:PODD) Omnipod 5 users now have a new way to control their automated insulin delivery system.
Novosound unveils ultrasonic blood pressure monitor
Novosound today announced the unveiling of an ultrasonic blood pressure monitor, miniaturizing blood pressure monitoring in wearable devices.
Distalmotion wins FDA de novo nod for Dexter surgical robot
Distalmotion announced today that it received FDA de novo approval for its Dexter surgical robot for adult inguinal hernia repair.
Vantis Vascular wins FDA nod for integrated microcatheter guide extension system
Vantis Vascular announced today that it received FDA 510(k) clearance for its CrossFast integrated microcatheter guide extension system.
Dexcom submits 15-day CGM to FDA, beats Street in Q3
Dexcom’s third-quarter earnings report included news of a significant submission to the FDA for the company’s latest-generation technology.
Medtronic wins CE mark for Evolut FX+
Medtronic (NYSE:MDT) announced today that it received CE mark approval for its Evolut FX+ transcatheter aortic valve implantation (TAVI) system.