Bracco Imaging Secures ANVISA Clearance for AiMIFY to Expand AI-Enhanced MRI Diagnostics in Brazil

Bracco Imaging has received ANVISA (Agência Nacional de Vigilância Sanitária) approval in Brazil for AiMIFY, the AI-powered brain MRI software developed in partnership with Subtle Medical. The regulatory clearance marks a key step in the companies’ broader global rollout, building on earlier authorizations from the FDA and CE marking in Europe. Bracco now plans to introduce the technology to imaging centers across Brazil, a growing market for advanced diagnostic solutions in Latin America.

AiMIFY is designed to enhance the contrast of brain MRI scans after administration of a labelled dose of gadolinium-based contrast agents, providing up to twice the original contrast level. This improvement supports radiologists in assessing subtle or poorly enhanced lesions. The software has shown consistent performance across a wide range of validation studies that included diverse patient groups, pathologies, lesion sizes, scanner manufacturers, and imaging parameters.

Sascha Daeuber, Global Radiology Platform Leader at Bracco Imaging, said the ANVISA clearance reinforces the company’s commitment to expanding access to precision imaging technologies. “We are proud to bring AiMIFY to Brazil following ANVISA approval, building on our momentum as a global leader in diagnostic imaging innovation,” he said. “This milestone reflects our continued commitment to advancing precision diagnostics by enabling radiologists to gain clearer, more confident insights from brain MRI.”

The company views Brazil as a strategic market for MRI, a modality widely used throughout Latin America. “MRI is the preferred imaging modality in Latin America and Bracco has built the most comprehensive portfolio in this field, covering innovative contrast agents, injectors and IT solutions,” said Tommaso Montemurno, General Manager for Latin America at Bracco Imaging. “The ANVISA approval of AiMIFY reinforces our regional commitment to support radiologists with innovative tools that help elevate diagnostic standards.”

Subtle Medical noted that the approval strengthens their mission to broaden access to advanced imaging without requiring new hardware. “We are excited to see AiMIFY boost the impact of MRI imaging in Brazil,” said Josh Gurewitz, Chief Commercial Officer at Subtle Medical. “With the combined power of AiMIFY and SubtleHD, imaging providers in Brazil can unlock greater diagnostic precision and operational efficiency without costly hardware upgrades.”