Regulatory Approvals

Formus Labs today announced it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for Formus Hip as the first...

Intuitive Surgical(Nasdaq: ISRG)+ announced that the FDA cleared its da Vinci SP surgical robot for simple prostatectomy. The clearance, which includes prostatectomy as a representative procedure,...

Zeiss announced the US Food and Drug Administration (FDA) approval of CT LUCIA 621P Monofocal IOL.1 This aspheric, monofocal, single-piece C-loop IOL features optic (ZO)...

Insulet Corporation (NASDAQ: PODD) (Insulet or the Company), the global leader in tubeless insulin pump technology with its Omnipod® brand of products, announced the FDA clearance of...

 Medtronic plc (NYSE: MDT), the global leader in medical technology, announced U.S. Food and Drug Administration (FDA) approval of its MiniMed™ 780G system with the Guardian™...

GE HealthCare (Nasdaq: GEHC) today announced US FDA 510(k) clearance of its CARESCAPE Canvas patient monitoring platform for precise, flexible patient care. CARESCAPE Canvas and CARESCAPE ONE are...

Global Leader in Cardiac Rhythm Technology Solutions Expands Therapies for the Treatment of Chronic Intractable Pain with a New Approach to Managing Spinal Cord...

Masimo (NASDAQ: MASI) announced that the Rad-G® with Temperature has received FDA 510(k) clearance. Rad-G with Temperature is a rugged, versatile, handheld monitor that provides clinically...

Moon Surgical has announced that its Maestro System is now CE Marked under the Medical Device Regulation (EU) 2017/745. “This new milestone is a testament to...