Regulatory Approvals

Momentis Surgical announced the FDA granted 510(k) clearance for its second-generation Anovo surgical robot. Last month, Anovo received clearance for use in single-site, abdominal...

The Centers for Medicare & Medicaid Services has granted transitional pass-through payment for Limaca Medical's Precision-GI™ motorised endoscopic biopsy device. Limaca's endoscopic device is...

SimBioSys received its second FDA 510(k) clearance for TumorSight Viz to expand its use by breast surgeons in the U.S. Chicago-based SimBioSys picked up an...

Corin received FDA 510(k) clearance for its Icona femoral stem implant for total hip arthroplasty (THA). This clearance comes just one month after Corin...

SYNDEO Medical, a Belgium-based leader in diagnostic and interventional procedural solutions, announces that its two flagship product brands, SYNDEOPack Interventional Procedure Packs™ and Xssential...

Zeta Surgical announced the FDA granted 510(k) clearance for its Zeta Navigation System for expanded capabilities. The clearance applies to use with expanded instruments...

Imbed Biosciences announced U.S. Food and Drug Administration 510(k) clearance to market Microlyte Ag/Lidocaine, the first antimicrobial wound dressing to integrate lidocaine for the management...

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....