
Varian wins FDA nod for new Ethos radiotherapy offering
Siemens Healthineers‘ Varian announced today that it received FDA 510(k) clearance for a new functionality for its Ethos therapy system.
Siemens Healthineers‘ Varian announced today that it received FDA 510(k) clearance for a new functionality for its Ethos therapy system.
The South Korean company’s Epysqli is now FDA-approved for paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome in the U.S., having grabbed the lead in the Soliris biosimilar market in Europe.
Restore Medical announced today that it received FDA breakthrough device designation for its ContraBand heart failure treatment device.
Imperative Care announced today that the FDA granted 510(k) clearance for its Zoom 6F insert catheters for ischemic stroke procedures.
Hyperfine (Nasdaq:HYPR) announced today that the FDA cleared its ninth-generation AI-powered Swoop system software.
Smith+Nephew (NYSE: SNN)+
announced today that it received FDA 510(k) clearance for its new Catalystem primary hip system.
Philips (NYSE: PHG)+
announced today that it received FDA clearance for its latest pathology solution, the IntelliSite Pathology Solution 5.1.
Oticon Medical announced today that the FDA granted clearance for its Sentio transcutaneous bone conduction hearing system.
REMSleep Holdings Inc has received FDA 510(K) clearance for its new DeltaWave nasal pillow CPAP interface mask. The DeltaWave is designed to enhance comfort and maintain natural breathing patterns, aiming to address common issues that lead to therapy discontinuation
ImmersiveTouch announced today that it received FDA 510(k) clearance for its ImmersiveAR augmented reality technology platform.