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FDA AI Approvals Surge Past 1k for Radiology

Summary by The Imaging Wire
The number of AI-enabled medical devices granted FDA marketing authorization for radiology surged past the 1k mark in the latest update from the agency. The numbers show that radiology’s share of authorizations remains stable at just over three-quarters of total approvals. The FDA regularly releases the list in what’s become a closely watched barometer of both total approvals as well as which medical specialties are most active in AI. Radiology…
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The Imaging Wire broke the news in on Thursday, December 11, 2025.
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