Regulatory Approvals

NeurAxis wins expanded FDA clearance for non-implanted neurostim for pain relief

NeurAxis shared the FDA granted an expanded 510(k) clearance for its IB-Stim non-implanted nerve stimulator. IB-Stim delivers nerve stimulation for functional abdominal pain relief....

FDA clears Quanta home hemodialysis system

Quanta Dialysis Technologies received FDA 510(k) clearance for the use of its dialysis system in the home. Beverly, Massachusetts–based Quanta said in a news...

Distalmotion wins FDA de novo nod for Dexter surgical robot

Distalmotion received FDA de novo approval for its Dexter surgical robot for adult inguinal hernia repair. Lausanne, Switzerland–based Distalmotion can now bring Dexter to...

Vantis Vascular wins FDA nod for integrated microcatheter guide extension system

Vantis Vascular received FDA 510(k) clearance for its CrossFast integrated microcatheter guide extension system. San Jose, California-based Vantis develops the CrossFast system along with...

FDA clears Lapsi Health’s digital stethoscope

Dutch-Finnish startup Lapsi Health has gained U.S. Food and Drug Administration clearance for its new digital stethoscope, Keikku. Unlike traditional stethoscopes, Keikku (translated from Finnish...

Peytant wins FDA de novo nod for covered stent system

The FDA granted marketing authorization for Peytant Solutions' AMStent tracheobronchial covered stent system. Plymouth, Minnesota-based Peytant designed its AMStent to treat pulmonary obstructions caused...

FDA clears Gentuity imaging system for coronary interventions

Gentuity received FDA 510(k) clearance for its HF-OCT imaging system with the Vis-Rx micro-imaging catheter. Sudbury, Massachusetts-based Gentuity received approval for the technology for...

Novocure wins FDA nod for lung cancer treatment wearable

Novocure announced the FDA treated its Optune Lua wearable device for treating metastatic non-small cell lung cancer. Optune Lua uses tumor-treating fields (TTFields) to exert...

CMR Surgical wins FDA clearance for next-gen Versius Surgical System

CMR Surgical announced the U.S. FDA has granted marketing authorisation for the Versius Surgical System, paving the way for a next-generation versatile, adaptable, and...
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