Regulatory Approvals

Avita Medical, a leading therapeutic acute wound care company, today announced it has received the CE Mark under the European Union Medical Device Regulation...

B. Braun acquired True Digital Surgery (TDS), a company specialising in digital robotic-assisted 3D surgical microscopy. The company said its acquisition highlights its commitment to...

Pulnovo Medical announced it received two FDA investigational device exemption (IDE) approvals for its technology. Shanghai-based Pulnovo won IDEs for its pulmonary artery denervation (PADN)...

Centinel Spine, the leading global medical device company focused exclusively on treating cervical and lumbar spinal disease with the most complete and clinically-proven total...

UK-based Naitive Technologies has gained 510(k) clearance from the US Food and Drug Administration (FDA) for OsteoSight, an artificial intelligence (AI)-powered software for bone...

inTRAvent Medical Partners LP, a medical device company dedicated to bringing intra-operative imaging and navigation to the bedside to improve neurosurgical procedures, today announced...

Varian announced its Embozene microspheres have received CE mark for genicular artery embolisation (GAE) to treat knee osteoarthritis. The regulatory clearance makes Embozene the first...

Danish medtech company Neurescue has gained a European CE mark for its catheter to address non-shockable cardiac arrest. The company’s catheter is used in conjunction...

The US Food and Drug Administration (FDA) has cleared Microbot Medical’s LIBERTY, a single-use, remotely operated robotic system for peripheral endovascular procedures. Microbot completed the...