Regulatory Approvals

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...

Distalmotion announced it received FDA 510(k) clearance for the use of its Dexter surgical robot in adult cholecystectomy (gallbladder removal). Lausanne, Switzerland–based Distalmotion already holds...

Reflow Medical, Inc., one of the leading developer of innovative medical devices focused on complex cardiovascular disease, announced that the U.S. Food and Drug...

AnX Robotica announced today that it received FDA 510(k) clearance for its MotiliCap technology with MotiliScan companion software. The company said in a news release...