Predictive Health Intelligence’s flagship product, hepatoSIGHT, a case-finding search engine that enables clinicians to identify people potentially at risk for liver disease, has now received Class I clearance from the Medicines and Healthcare products Regulatory Agency (MHRA).
AtriCure (Nasdaq: ATRC)+
announced today that it received an expanded indication for its AtriClip devices in Europe.
SAN FRANCISCO and MILWAUKEE, Aug. 21, 2024 /PRNewswire/ — Cytovale®, a commercial-stage medical diagnostics company focused on advancing early detection technologies to diagnose fast-moving and immune-mediated diseases, today announced that the Froedtert & the Medical College of Wisconsin health network is now screening patients with IntelliSep® in a pilot at its flagship hospital, Froedtert Hospital in Milwaukee.
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.