Teleflex wins FDA nod for intra-aortic balloon pump
April 1, 2025
Teleflex (NYSE: TFX)+
announced today that it received FDA 510(k) clearance for its AC Range intra-aortic balloon pump (IABP).
Teleflex (NYSE: TFX)+
announced today that it received FDA 510(k) clearance for its AC Range intra-aortic balloon pump (IABP).
Boston Scientific (NYSE: BSX) has received FDA clearance for its Bolt intravascular lithotripsy (IVL) system, according to the FDA’s 510(k) database.
PARIS, March 31, 2025 /PRNewswire/ — AZmed, one of the leading AI companies in medical imaging, today announced that it has received two new U.S. Food and Drug Administration (FDA) clearances for its AI tool AZchest. The clearances include applications intended to assist radiologists in the interpretation and detection of chest X-rays for lung nodules and triage capabilities for pneumothorax and pleural effusion.
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.