Abbott (NYSE: ABT)+
announced today that an FDA advisory committee ruled that the benefits of its TriClip outweigh the risks in treating tricuspid regurgitation (TR).
Proscia, a leading provider of digital and computational pathology solutions, has received 510(k) clearance from the United States (U.S.) Food and Drug Administration (FDA) for its Concentriq AP-Dx. The digital pathology solution was cleared for the purpose of primary diagnosis.
Viz.ai announced that it received FDA 510(k) clearance for its Viz ICH Plus algorithm for providing volume measurements of brain bleeds.
Fresenius Medical Care announced today that it received FDA clearance for its 5008X hemodialysis system.
ROSWELL, Ga., Feb. 6, 2024 /PRNewswire/ — StimLabs® announces FDA 510(k) clearance of Corplex P, the pioneering human umbilical cord-derived medical device. This first-of-its-kind clearance marks a significant milestone for the wound care industry and highlights StimLabs’ position at its forefront.
Boston Scientific (NYSE: BSX)+
announced today that the FDA approved an expanded indication for its WaveWriter spinal cord stimulation (SCS) systems.
Philips (NYSE: PHG)+
announced today that it received FDA 510(k) clearance for its latest IntelliVue patient monitor software.
Hologic (Nasdaq: HOLX)+
announced that the FDA granted clearance for its Genius digital diagnostics system with the Genius cervical AI algorithm.
The Evoque valve will serve patients with few treatment options, wrote RBC analyst Shagun Singh.
Philips (NYSE: PHG)+
announced today that the FDA granted 510(k) clearance to its latest TEE transducer technology.