Regulatory Approvals

Terumo Aortic announces FDA approval of dissection and transection indication expansion for the RelayPro stent graft system in the USA

Terumo Aortic announced that the US Food and Drug Administration (FDA) has granted approval of the RelayPro thoracic stent graft device for the treatment of...

Formus Labs Hip Platform Receives FDA Clearance

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...

FDA clears Intuitive da Vinci surgical robot for prostatectomy

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,...

FDA approves CT LUCIA 621P Monofocal IOL from Zeiss

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 Announces FDA Clearance of Omnipod GO™, a First-of-its-Kind Basal-Only Insulin Pod, Further Simplifying Life for People with Type 2 Diabetes

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...

FDA Approves Medtronic MiniMed™ 780G System – World’s First Insulin Pump with Meal Detection Technology* Featuring 5-Minute Auto Corrections†§

 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 receives FDA approval for CARESCAPE Canvas platform

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...

FDA Approval for BIOTRONIK’s Prospera™ Spinal Cord Stimulation System

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 Announces FDA Clearance of the Rad-G® with Temperature

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...
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