Regulatory Approvals

Magstim earns FDA clearance for transcranial magnetic stimulation that treats depression, OCD

Magstim announced that the FDA cleared its next-generation Horizon Inspire system for delivering transcranial magnetic stimulation (TMS). Clearance paves the way for the use...

Momentis Surgical wins FDA nod for second-gen surgical robot

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...

Limaca’s Precision-GI™ granted CMS Transitional Pass-Through payment

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...

FDA clears SimBioSys clinical decision support tech for breast cancer surgery

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 wins FDA clearance for new femoral stem

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 Announces European MDR Approval for Two Product Brands

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 wins FDA nod for AI-powered surgical nav tech

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...

FDA clears Imbed Biosciences’ Microlyte Ag/ Lidocaine

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...

FDA grants approval to commence trial of R3 Vascular’s scaffold

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...
1...333435...114Page 34 of 114

Latest articles