Regulatory Approvals

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...

Foldax this week announced it secured regulatory approval in India for its Tria mitral heart valve. The approval from India’s Central Drugs Standard Control Organization...

Penumbra has introduced Ruby XL System, the detachable embolisation coil, which has also received clearance from the US Food and Drug Administration (FDA). The system...

French artificial intelligence (AI)-based medical imaging company Avicenna.ai has secured CE marks for a pair of radiologic screening tools to detect fractures from CT...

Hyperfine, the health technology company that has redefined brain imaging with the first FDA-cleared AI-powered portable MRI system for the brain—the Swoop® system—announced FDA...

BiVacor announced it received FDA breakthrough device designation for its Total Artificial Heart (TAH) system. The designation supports the TAH as a bridge to transplant...

CoreMap received FDA investigational device exemption (IDE) to extend its electrophysiology (EP) mapping trial to the U.S. The study aims to evaluate the safety and...