MedTech News
hepatoSIGHT liver disease tool receives MHRA clearance
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 wins expanded CE mark for left atrial appendage device
AtriCure (Nasdaq: ATRC)+
announced today that it received an expanded indication for its AtriClip devices in Europe.
Cytovale Expands FDA-Cleared Sepsis Detection Technology to the Froedtert & the Medical College of Wisconsin Health Network
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 wins FDA de novo nod for CPAP, ventilation hose cleaner
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 wins FDA clearance, breakthrough nod for pelvic fixation implant
Si-Bone this week announced it received FDA 510(k) clearance and FDA breakthrough device designation for its iFuse Torq TNT Implant System.
FDA approves label expansion for Abbott HeartMate 3 LVAD to remove aspirin from treatment regimen
Abbott (NYSE: ABT)+
announced today that the FDA approved a label change for its HeartMate 3 left ventricular assist device (LVAD).
FDA clears next-gen surgical robot from Procept Biorobotics
Procept BioRobotics (Nasdaq:PRCT) announced today that it received FDA 510(k) clearance for its next-generation Hydros robotic surgery system.
AlgoDx receives FDA clearance for sepsis detection software
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.