SoClean wins FDA de novo nod for CPAP, ventilation hose cleaner
August 21, 2024
SoClean this week announced it was granted FDA de novo clearance for its at-home CPAP mask and ventilation hose cleaner SoClean 3+.
SoClean this week announced it was granted FDA de novo clearance for its at-home CPAP mask and ventilation hose cleaner SoClean 3+.
Si-Bone this week announced it received FDA 510(k) clearance and FDA breakthrough device designation for its iFuse Torq TNT Implant System.
Abbott (NYSE: ABT)+
announced today that the FDA approved a label change for its HeartMate 3 left ventricular assist device (LVAD).
Procept BioRobotics (Nasdaq:PRCT) announced today that it received FDA 510(k) clearance for its next-generation Hydros robotic surgery system.
AlgoDx, a leading medical AI company with EU and UK-approved ML-based software for sepsis prediction in commercial use, has announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its sepsis detection software using a proprietary algorithm, NAVOY CDS. This milestone marks a major step forward in AlgoDx’s expansion into the U.S. market.
Ocutech, Inc., in collaboration with electrical, software and mechanical engineering experts, has announced the limited first release of a new ultrasonic sensor device
Enovis (NYSE: ENOV)+ announced today that it unveiled its STAR Ankle system with new e+ Polyethylene.
Following a nearly decade-long effort, Delcath Systems finally won the FDA’s greenlight for its Hepzato Kit for the liver-directed treatment of adult patients with metastatic uveal melanoma.
These zinc-air batteries, smaller than a grain of sand, could help miniscule robots sense and respond to their environment.
Intended to supplement medications, the six-week, app-based treatment will cost $50 on a cash-pay basis.