Regulatory Approvals

xDot Medical can begin FDA IDE study of vascular closure device

xDot Medical has received FDA investigational device exemption (IDE) approval to begin a pivotal clinical trial of its Access Management System (AMS) for closing...

Movmedix gets FDA nod for third-gen synthetic shoulder implant

Movmedix has received FDA 510(k) clearance for its third-generation LARS ACJ synthetic ligament implant, marking the company's first U.S. regulatory approval and enabling the...

Median Technologies’ eyonis LCS obtains CE marking

Median Technologies has announced that its AI-powered software, eyonis® LCS, has obtained CE marking as a Class IIb medical device. Granted by the French...

Materna closes $5 Million B3 financing to fuel growth

Materna Medical, a Mountain View, California-based OBGYN platform company, has successfully closed a $5 million B3 financing round. The investment was led by InnovaHealth...

Novocure earns CE mark for Optune Pax pancreatic cancer treatment device

Novocure has successfully secured CE mark approval in Europe for its Optune Pax device, a wearable system designed to treat adults with locally advanced...

Bioness wins FDA clearance for portable neurostimulator for stroke recovery

Bioness Medical has received FDA 510(k) clearance for its PoNS (Portable Neuromodulation Stimulator) system to treat dynamic gait deficit caused by chronic stroke symptoms....

United Therapeutics gets FDA green light for lung perfusion device

United Therapeutics announced that the US Food and Drug Administration (FDA) has granted Premarket Approval (PMA) for its LungFX perfusion device. The system, which...

Valgen earns CE mark for mitral valve repair system

Valgen Medtech has received CE mark approval for its DragonFly transcatheter mitral valve repair system for the treatment of functional mitral regurgitation (FMR), expanding...

AorticLab earns expanded CE mark for embolic protection device

AorticLab has received an expanded CE mark for its FLOWer embolic protection device, allowing broader use in transcatheter cardiovascular procedures beyond TAVI. The device is...
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