4C Medical Technologies announced today that the FDA granted breakthrough device designation for its AltaValve system.

Outset paused shipments of its TabloCart with prefiltration last year after receiving a warning letter from the FDA.

MISGAV, Israel, May 6, 2024 /PRNewswire/ — ZygoFix Ltd. a portfolio company of The Trendlines Group Ltd. (“Trendlines”) announced that it received regulatory clearance from the United States Food and Drug Administration (FDA clearance) for its zLOCK Lumbar Facet Fixation System. This achievement was supported by compelling clinical evidence from the company’s ongoing European clinical study, marking a significant advancement in spinal fusion technology..

In an advancement in gastrointestinal health, researchers from Johns Hopkins University have developed the Multifunctional Ablative Gastrointestinal Imaging Capsule (MAGIC)—a gastrointestinal imaging capsule for esophagus surveillance and interventions.

Scientia Vascular,is thrilled to announce the FDA clearance of two uniquely engineered catheters: the Plato 17 and the Socrates 38.

Medtronic (NYSE: MDT)+
today announced its Symplicity Spyral renal denervation system won National Medical Products Administration (NMPA) approval in China.

Owlet announced that it received CE mark approval for its Dream Sock device for monitoring the vital signs of infants.

WASHINGTON, May 2, 2024 /PRNewswire/ — MCRA, the leading privately held independent medical device, diagnostics, and biologics Clinical Research Organization (CRO) and advisory firm is pleased to announce its role in the successful granting of Darmiyan’s De Novo request for BrainSee by the U.S. Food and Drug Administration (FDA).