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25th World Congress on Cancer Science and Therapy

Baltimore, USA


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.
 
Robert Ochs is the Director of the Division of Radiological Health within the U.S. Food and Drug Administration, Center for Devices and Radiological Health. He received his Ph.D. in Biomedical Physics from the University of California, Los Angeles. The Division of Radiological Health at FDA is responsible for pre-market review compliance, and post-market surveillance for radiological medical devices (e.g., CT, MRI, mammography, ultrasound, radiation oncology devices and radiological image analysis software) as well as the regulation of medical and non-medical radiation emitting electronic products (e.g., lasers, microwaves).

 

Abstract

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