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Evaluating Medical Devices Using Reader Studies

Authors:
Poster Author(s)
Younis, Seif, FDA/CDRH (Student); Samuelson, Frank FDA/CDRH (Mentor)
Center:
Contributing Office
Center for Devices and Radiological Health

Abstract

Poster Abstract

Medical imaging provides important information on patients' current health. As a result, the FDA continues to evaluate the effectiveness of diagnostic imaging tests by utilizing reader studies for evaluating readers' diagnostic decisions. In the interest of teaching others about device evaluation with reader studies, we are developing software for conducting reader studies in classrooms and online learning environments. This software will take the form of a web application so it can be used by anyone with a web browser. This web application is an opportunity to teach radiologists, regulators, and other scientists about the role of reader studies in device evaluation.

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