Bracco Diagnostics and Subtle Medical Announce FDA Clearance of AiMIFY™ Software

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^TM, 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.

“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^TM 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.”

Bracco and Subtle will participate in the 110th Radiological Society of North America’s (RSNA) Scientific Assembly and Annual Meeting Dec. 1-5, 2024 in Chicago. To learn more, visit the Bracco booth #3300 and the Subtle Medical booth #4739 in the South Hall, Level 3. Additional information about RSNA Technical Exhibits can be found here.

AiMIFY is manufactured for Bracco Diagnostics Inc. by Subtle Medical Inc. – Menlo Park, CA, USA 94025.

AiMIFY is a trademark of Bracco Imaging S.p.A.