FDA Clears Bracco, Subtle Medical Collaborative AI-Powered, Brain MRI Software

Bracco Diagnostics Inc. and Subtle Medical, Inc. have received FDA clearance as a Class II software as a medical device (SaMD) for their collaborative AI-powered MRI brain software, AiMIFY. This software, exclusively from Bracco and Subtle Medical, is designed to significantly enhance MRI of the brain, particularly for detecting small and poorly enhanced lesions.

“This FDA clearance marks a significant milestone for our innovative product, showcasing its potential to transform MRI,” said Fulvio Renoldi Bracco, Vice Chairman & Chief Executive Officer of Bracco Imaging S.p.A. “By integrating Bracco’s expertise in contrast imaging with Subtle Medical’s cutting-edge deep-learning technology, we are poised to redefine diagnostic precision and efficiency, setting new standards in the field for the ultimate benefit of the patients.”

AiMIFY leverages advanced AI technology 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 (GBCAs). This enhancement provides radiologists and neuroradiologists with clearer, more detailed images, improving the visibility of small and large lesions compared to standard post-contrast images. The software’s effectiveness has been validated across diverse test data, including various patient demographics, pathologies, lesion sizes, image scanner vendors, MRI sequences, and acquisition orientations.

“We partnered with Bracco to unlock the potential that AI brings to medical imaging,” said Ajit Shankaranarayanan, PhD, Chief Product Officer at Subtle Medical. “The FDA clearance represents a significant milestone for both companies, as we join forces to empower radiological professionals and improve outcomes for patients worldwide with this innovative AI-powered medical imaging solution.”