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.
Paragonix Technologies this week announced it received FDA 510(k) clearance for its KidneyVault donor kidney preservation system.
Distalmotion announced today that it received FDA de novo approval for its Dexter surgical robot for adult inguinal hernia repair.
Vantis Vascular announced today that it received FDA 510(k) clearance for its CrossFast integrated microcatheter guide extension system.
Medtronic (NYSE:MDT) announced today that it received CE mark approval for its Evolut FX+ transcatheter aortic valve implantation (TAVI) system.
Medtronic (NYSE:MDT) today said it received FDA approval for its Affera mapping and ablation system with the Sphere-9 catheter.
The agency cleared one of two 510(k) submissions iRhythm filed for the heart monitor after receiving a warning letter from the agency last year.
Medtronic (NYSE: MDT)+
announced today that it received FDA investigational device exemption (IDE) for its Prevail drug-coated balloon (DCB).
A potentially cost-saving UK digital health innovation that is awaiting NHS England funding, more than two years after NICE recommended its national adoption in the NHS, will soon be made available to patients in the US after it secured FDA clearance.
Gentuity announced today that it received FDA 510(k) clearance for its HF-OCT imaging system with the Vis-Rx micro-imaging catheter.