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Daniel M Krainak & Robert Ochs

Food and Drug Administration, USA

Biography

Daniel Krainak obtained his PhD in Biomedical Engineering from Northwestern University and completed a Post-doctoral fellowship at CDRH investigating diffusion tensor imaging. He has been a reviewer in the division of Radiological Health since 2012 with an emphasis on magnetic resonance imaging technologies. He participated in the review of radiological devices, imaging biomarkers, and radiological imaging in therapeutic product clinical trials.

Abstract

Abstract : FDA/CDRH perspectives on imaging biomarkers: Technical performance and analytical validation