Bracco Diagnostics and Subtle Medical have secured U.S. Food and Drug Administration (FDA) clearance for their collaborative AI-powered software AiMIFY for brain MRI.
AiMIFY is designed to amplify the contrast enhancement of brain MR images up to two times the level obtained with a labeled dose of gadolinium-based contrast agents, according to the companies. This enhancement improves the visibility of small and large lesions compared with standard postcontrast images and has been validated across a range of test data, including pathologies, lesion sizes, image scanner vendors, MRI sequences, patient demographics, and acquisition orientations, the companies said.
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