SiBionics unveils ‘world’s thinnest’ CGM, earns CE mark
March 26, 2025
SiBionics announced today that it unveiled its GS3 continuous glucose monitor (CGM), which now has CE mark approval.
SiBionics announced today that it unveiled its GS3 continuous glucose monitor (CGM), which now has CE mark approval.
SCOTTSDALE, Ariz., March 20, 2025 /PRNewswire/ — Anuncia Medical, Inc. (“Anuncia”), a pioneering company in CSF management and neurocritical care, has received Breakthrough Device Designation from the FDA for its ReFlow® EVD, an innovative solution for external ventricular drains (EVDs) used to manage brain swelling and elevated intracranial pressure.
Sibel Health announced today that it closed a $30 million equity financing and earned its seventh FDA 510(k) clearance.
Monogram Technologies secured 510(k) clearance for its robotic knee replacement system
Moon Surgical announced today that it received FDA clearance for ScoPilot, a Nvidia-enabled platform for its Maestro surgical robot.
Lifeward (Nasdaq:LFWD) announced today that it received FDA 510(k) clearance for its latest-generation personal exoskeleton device, ReWalk 7.
Spineart and eCential Robotics today announced the receipt of FDA 510(k) clearance for the use of an application for robotic navigation.
Perfuze announced today that it received FDA 510(k) clearance for its Zipline access catheter and secured significant funding.
Using Nvidia and GE Healthcare technology, the robotic surgery system is intended to help doctors detect lung cancer earlier.
HERZLIYA, Israel and WILMINGTON, Del., March 13, 2025 /PRNewswire/ — Valcare Medical Inc., a leading innovator in transcatheter-based mitral solutions, today announced the U.S. Food and Drug Administration (FDA) has approved the AMEND™ Trans-Septal System for investigational device exemption (IDE) application to commence an Early Feasibility Study (EFS).