Regulatory Approvals

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...

LEM Surgical wins new FDA clearance for humanoid surgical robot

LEM Surgical has received a new FDA 510(k) clearance for its Dynamis robotic surgical system, expanding the platform’s capabilities in spine surgery and marking...

Masimo gets FDA nod for AI-enabled opioid-induced respiratory depression detection tech

Masimo has received FDA clearance for an AI-enabled opioid-induced respiratory depression (OIRD) detection capability designed for its Radius VSM wearable continuous monitoring system. The technology...

FiberSense to bring new CGM to European market with CE mark

FiberSense has received CE mark approval for its continuous glucose monitoring (CGM) system, allowing the company to move toward commercialization in selected European markets. The...

AngioDynamics wins FDA IDE for feasibility study of NanoKnife in BPH

AngioDynamics has received FDA investigational device exemption (IDE) approval to begin the RELIEF feasibility study, evaluating its NanoKnife system for treating lower urinary tract...

Distalmotion gets FDA nod to expand Dexter surgical robot indications to gynecology

Distalmotion has received FDA 510(k) clearance to expand the use of its Dexter surgical robot across additional gynecologic procedures, including sacrocolpopexy, sacrocervicopexy, sacrohysteropexy, and...
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