Regulatory Approvals

ANACONDA Biomed, a medical technology company developing next-generation thrombectomy systems for the treatment of ischemic stroke, has announced that it has received CE Mark...

Brain Navi Biotechnology announced today that it received FDA 510(k) clearance for its NaoTrac stereotaxic guiding surgical robotic device. Zhubei City, Taiwan–based Brain Navi —...

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...