Summary: Bracco Diagnostics and Subtle Medical’s AI-powered software, AiMIFY, has received FDA clearance as a Class II medical device for brain MRI, designed to improve contrast and aid radiologists in detecting lesions.

Key Takeaways

  • AiMIFY, an AI-powered software developed by Bracco Diagnostics and Subtle Medical, has received FDA clearance as a Class II medical device for brain MRI, improving the detection of small and poorly enhanced lesions.
  • AiMIFY has been validated across various patient demographics and MRI systems, marking a significant step in advancing MRI technology through AI.
  • The software enhances contrast in brain MR images, potentially doubling the contrast level achieved with traditional gadolinium-based agents, helping radiologists identify lesions more clearly.

Bracco Diagnostics Inc., a U.S. subsidiary of Bracco Imaging S.p.A., and Subtle Medical, Inc., have announced that their AI-powered software, AiMIFY, has receive U.S. FDA clearance as a class II medical device for brain MRI. This software, exclusive to Bracco and Subtle Medical, enhances brain MRI, particularly in detecting small and poorly enhanced lesions.

“This FDA clearance marks a significant milestone for our innovative product, showcasing its potential to transform MRI,” says Fulvio Renoldi Bracco, vice chairman and CEO of Bracco Imaging. “By combining Bracco’s expertise in contrast imaging with Subtle Medical’s deep-learning technology, we aim to redefine diagnostic precision and efficiency for the benefit of patients.”

AiMIFY Boosts MRI Contrast

AiMIFY enhances contrast in brain MR images, increasing it up to twice the level typically seen with gadolinium-based contrast agents. This results in clearer, more detailed images, aiding radiologists and neuroradiologists in identifying lesions more effectively. The software has been tested on a wide range of patient demographics, pathologies, lesion sizes, MRI scanner vendors, and acquisition orientations.

“We partnered with Bracco to unlock the potential of AI in medical imaging,” says Ajit Shankaranarayanan, PhD, chief product officer at Subtle Medical. “This FDA clearance is a key milestone as we work together to empower radiologists and improve patient outcomes worldwide with this innovative solution.”