Bracco Imaging Achieves New Global Milestone with ANVISA Clearance of AiMIFY™ in Brazil
Regulatory approval expands access to AI-Powered diagnostics across Latin America, following FDA and CE Mark clearances
Bracco Imaging S.p.A., a global leader in diagnostic imaging, and Subtle Medical, Inc., a pioneering innovator in artificial intelligence (AI)-powered medical imaging software, announced today that AiMIFY™, their jointly developed AI-powered software for magnetic resonance imaging (MRI) of the brain, has received ANVISA (Agência Nacional de Vigilância Sanitária) approval in Brazil.
This milestone marks the latest achievement in Bracco’s global expansion of next generation imaging solutions, following previous clearances by the U.S. Food and Drug Administration (FDA) and (Conformité Européenne) CE Marking in Europe.
With ANVISA approval, AiMIFY™ is now commercially available to all imaging providers across Brazil, enabling broader access to advanced diagnostic innovation in one of Latin America's most strategically important healthcare markets.
AiMIFY™ leverages advanced AI technology to amplify the contrast enhancement of brain MRI scans after administration of a labelled dose of Gadolinium-Based Contrast Agents (GBCAs) up to twice the initial value. This provides radiologists with improved contrast information - particularly aiding in the visualization of small and poorly enhanced lesions. AiMIFY™ has demonstrated consistent performance across a wide range of validation data, including diverse patient demographics, pathologies, lesion sizes, scanner vendors, MRI sequences, and acquisition orientations.
GL-AIM-2500022