HighLife, a company focused on development of a novel trans-septal mitral valve replacement (TSMVR) system for moderate to severe mitral regurgitation (MR), has received...
CardioVia announced today that it received FDA clearance for its minimally invasive ViaOne epicardial access system.
The company designed its device to enable safe, precise...
ICU Medical, a worldwide leader in the development, manufacture and sale of innovative medical devices, has announced 510(k) regulatory clearance from the U.S. Food...
Inspira has completed the first real-world procedure of its extracorporeal blood circulation device at New York’s Westchester Medical Center.
The Israeli company’s Inspira Art100 system...
Paige, a leader in next-generation AI technology, announced the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device designation to Paige PanCancer Detect,...
The US Food and Drug Administration (FDA) has granted 510(k) clearance for restor3d’s cementless iTotal Identity CR 3DP Porous Total Knee Replacement System.
The company...
Bright Uro received FDA 510(k) clearance for its Glean urodynamic analyser system.
Glean, a comprehensive system, enables wireless, catheter-free urodynamics. Bright Uro aims to provide...
The US Food and Drug Administration (FDA) has granted expanded 510(k) clearance for Epitel’s REMI Wireless electroencephalogram (EEG) System for neurological monitoring in infants...
Osteoboost achieved a notable regulatory milestone by receiving De Novo classification from the U.S. Food and Drug Administration (FDA). This designation is significant not...
