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Medical Imaging Data Strategies for Catalyzing AI Medical Device Innovation.

J Imaging Inform Med

January 2025

Office of Science and Engineering Laboratories, Center for Devices and Radiological Health, U.S. Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD, 20993, USA.

Continuous and consistent access to quality medical imaging data stimulates innovations in artificial intelligence (AI) technologies for patient care. Breakthrough innovations in data-driven AI technologies are founded on seamless communication between data providers, data managers, data users and regulators or other evaluators to determine the standards for quality data. However, the complexity in imaging data quality and heterogeneous nature of AI-enabled medical devices and their intended uses presents several challenges limiting the clinical translation of novel AI technologies.

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