JD Supra

The Institute of Medicine’s Broad Recommendations for Replacing the 510(k) Clearance Process

On July 29, 2011, the Institute of Medicine of the National Academy of Sciences released its eagerly awaited report titled, “The FDA 510(k) Clearance Process at 35 Years.” The FDA had asked the ...
BMJ

The association between moderate and vigorous physical activity and time to medical clearance to return to play following sport-related concussion in youth ice-hockey players

1 Sport Injury Prevention Research Centre, Faculty of Kinesiology, University of Calgary, Calgary, Alberta, Canada 2 Department of Community Health Sciences, Cumming School of Medicine, University of ...
Case Western Reserve University

Swallowable Device to Detect Pre-cancerous Barrett's Esophagus Receives FDA 510(k) Clearance

Investigators at Case Western Reserve University School of Medicine, the Case Comprehensive Cancer Center and University Hospitals Cleveland Medical Center developed the test for early detection of ...
National Academies of Sciences%2c Engineering%2c and Medicine

Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years

Prior to the Medical Device Amendments (MDA) of 1976, medical devices generally had not undergone premarket review by the US Food and Drug Administration (FDA). The MDA created three classes of device ...
Hosted on MSN

US FDA medical device clearance demystified – what investors need to know

FDA classifies medical devices based on the type of device and the level of risk it poses Three main FDA clearances for medical devices are 510(k), de novo and pre-market approval Several ASX ...
Business Wire

Ibex Medical Analytics Receives First FDA 510(k) Clearance

BOSTON--(BUSINESS WIRE)--Ibex Medical Analytics (Ibex), the leader in AI-powered cancer diagnostics, today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for ...