CHICAGO, Aug. 22, 2024 /PRNewswire/ — Sibel Health announces two additional FDA-clearances enabling its advanced wearable sensors to operate with compatible third party software applications. In order to democratize vital signs globally, Sibel Health is committed to enabling widespread access to its advanced wearable sensors.
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