Regulatory Approvals

The US FDA has granted investigational device exemption (IDE) approval to commence the ELITE-BTK trial of MAGNITUDE, a drug-eluting bioresorbable scaffold. The trial is...

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....

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

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...

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...

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 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...