This section presents the latest developments, inventions, and revolutionary technologies that change the face of healthcare.
Wenzel Spine has received FDA clearance for its expandable sacroiliac (SI) fusion implant, panaSIa. ...
InspireMD has officially commenced the commercial launch of its CGuard Prime carotid stent system in the United States, following premarket approval (PMA) from the U.S. Food and Drug Administration (FDA)....
EmpNia™, a medical device company focused on advancing cancer treatment through precision technologies, has received clearance from the U.S. Food and Drug Administration (FDA) to market its latest innovation...
Cerapedics Inc. has received U.S. FDA premarket approval (PMA) for its PearlMatrix™ P-15 Peptide Enhanced Bone Graft, a Class III drug-device combination product. ...
BrainScope® has launched a new generation of its deep learning platform. The company, known for creating the first FDA-cleared AI/machine learning medical device in neurology, is building on its strong machine...
Guardant Health has announced that its Shield multi-cancer detection (MCD) blood test has been granted Breakthrough Device designation by the U.S. Food and Drug Administration (FDA). ...
BiVACOR, a clinical-stage medical device company, has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA) for its innovative Total Artificial Heart (TAH)....
Vanderbilt Health has successfully implanted a novel heart monitoring device, the V-LAP, in a patient for the first time as part of an ongoing clinical trial. The study is currently being conducted at only five centres across the United States....
Elucent Medical, a company specialising in guided surgical technologies, has announced that its EnVisio X1™ In-Body Spatial Intelligence™ System has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA). ...
Baebies has received Breakthrough Device Designation from the U.S. Food and Drug Administration for its Anti-Factor Xa test developed for the FINDER® platform. This is the first point-of-care test designed to monitor heparin therapy, delivering results in under 15 minutes using only 50 microlitres of whole blood....
