MedTech News
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.
New ultrasonic device launches to aid with vision loss after stroke and brain injury
Ocutech, Inc., in collaboration with electrical, software and mechanical engineering experts, has announced the limited first release of a new ultrasonic sensor device
Enovis unveils new ankle replacement system
Enovis (NYSE: ENOV)+ announced today that it unveiled its STAR Ankle system with new e+ Polyethylene.
Delcath Gets FDA Approval for Cancer Drug-Device Combo 10 Years After Rejection
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.
MIT engineers design tiny batteries for powering cell-sized robots
These zinc-air batteries, smaller than a grain of sand, could help miniscule robots sense and respond to their environment.
Otsuka Precision Health launches first digital therapeutic for depression
Intended to supplement medications, the six-week, app-based treatment will cost $50 on a cash-pay basis.
Stereotaxis wins CE mark for next-gen surgical robot, submits to FDA
Stereotaxis (NYSE:STXS) announced that it obtained CE mark in Europe and submitted an FDA 510(k) application for its next-generation surgical robot.