Added Day 1 Webcast and Presentations to Public Workshop – Physiological Closed-Loop Controlled Devices, October 13

The Food and Drug Administration (FDA) announced a public Workshop entitled “Physiological Closed-Loop Controlled (PCLC) Devices.” The topic discussed was challenges related to the design, development, and evaluation of critical care PCLC devices. FDA considers PCLC devices an emerging technology and held a workshop focusing on design, development and performance evaluation of PCLC systems intended…

Summary Information for: HYMOVIS

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General Considerations for Animal Studies for Medical Devices

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Meeting Notice: November 18-19 , 2015 Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee Meeting

 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-N-0001] Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY:  Food and Drug Administration, HHS. ACTION:  Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA).  The meeting…

FDA Notification about Bioprosthetic Aortic Valve Reduced Leaflet Motion

Date: 10/5/2015 Introduction Bioprosthetic aortic valves play a critically important role in improving the health and quality of life of many patients with severe aortic valve disease. Recently, advanced imaging studies detected reduced leaflet motion (i.e., impaired valve opening) in some bioprosthetic aortic valves. The cause and occurrence rate of reduced leaflet motion is currently…