Regulatory Approvals

Italy-based Bracco Imaging and Subtle Medical have obtained an EU CE mark for AiMIFY, a jointly developed software designed to enhance the imaging of...

The US Food and Drug Administration (FDA) has granted 510(k) clearance to Viz.ai for its Viz Subdural Plus module, designed for enhancing clinical decision-making. It...

GI Windows Surgical received FDA 510(k) clearance for its Flexagon self-forming magnet technology. The FDA granted clearance for the Flexagon laparoscopic and endoscopic delivery system....

InspireMD’s CGuard Prime Embolic Prevention System (EPS) has secured CE Mark approval under the European Medical Device Regulation (MDR) for stroke prevention. Leveraging MicroNet mesh,...

Creo Medical has achieved a significant milestone with its SpyderBlade Flex surgical device earning clearance from the US Food and Drug Administration (FDA). This...

Volta Medical announced a labelling update for its Volta AF-Xplorer decision support system following the publication of landmark clinical data showing the system’s efficacy...

Safe Group, a leading player in the field of medical devices for spine surgery, is pleased to announce that Frida, the innovative cervical plate...

TYBR Health, a medical device and regenerative medicine company, announced U.S. Food and Drug Administration (FDA) 510(k) clearance for the B3 GEL System. B3...

Amid the growing prevalence of hypertension in the EU, Italian health tech Newel Health has secured a CE mark for its Amicomed platform under...