The AI-powered software AiMIFY has received FDA clearance as a Class II software as a medical device (SaMD) for brain magnetic resonance imaging (MRI). Developed collaboratively by leaders in diagnostic imaging and AI-powered image acquisition, AiMIFY is designed to significantly enhance brain MRI, particularly in the detection of small and subtle lesions.
According to Fulvio Renoldi Bracco, Vice Chairman and CEO of Bracco Imaging S.p.A., this FDA clearance is an important milestone that demonstrates the potential of AiMIFY to advance MRI capabilities. “By combining our expertise in contrast imaging with Subtle Medical’s advanced deep-learning technology, we aim to set new standards in diagnostic precision and efficiency for the benefit of patients,” he said.
The AiMIFY software applies advanced AI algorithms to amplify contrast in brain MR images, achieving up to twice the enhancement level compared to standard gadolinium-based contrast agents (GBCAs). This increased image clarity supports radiologists and neuroradiologists in identifying lesions with greater detail than is possible with traditional post-contrast imaging.
Effectiveness of the software has been validated using a broad range of test data, encompassing diverse patient demographics, pathologies, lesion sizes, imaging devices, MRI sequences, and acquisition orientations.
Ajit Shankaranarayanan, PhD, Chief Product Officer at Subtle Medical, highlighted the collaboration’s goal to harness AI’s potential in medical imaging: “FDA clearance signifies a major step forward, enabling us to support radiological professionals and improve patient outcomes through this innovative solution.”
AiMIFY will be presented at the 110th Scientific Assembly and Annual Meeting of the Radiological Society of North America (RSNA), scheduled for December 1-5, 2024, in Chicago.
