Bracco Diagnostics Inc. and Subtle Medical Announce FDA Clearance of AiMIFY™ Software for Enhanced MRI

Barchart · 10/16 07:00

MONROE TOWNSHIP, N.J., Oct. 16, 2024 /PRNewswire/ -- Bracco Diagnostics Inc., a U.S. subsidiary of Bracco Imaging S.p.A, one of the world's leading companies in the diagnostic imaging business, and Subtle Medical, Inc., a pioneering innovator in artificial intelligence (AI)-powered image acquisition, are thrilled to announce that their collaborative AI-powered software, AiMIFY, has received FDA clearance as a Class II software as a medical device (SaMD) for magnetic resonance imaging (MRI) of the brain. This groundbreaking software, exclusively from Bracco and Subtle Medical, is designed to significantly enhance MRI of the brain, particularly for detecting small and poorly enhanced lesions.

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