Bracco Imaging S.p.A., a global leader in diagnostic imaging, and Subtle Medical, Inc., a pioneering innovator in artificial intelligence (AI)-powered image acquisition, announced that AiMIFY™, their jointly developed AI-powered software for magnetic resonance imaging (MRI) of the brain, has received the CE (Conformité Européenne) Mark under the European Medical Device Regulation (MDR). This regulatory milestone confirms the compliance of AiMIFY™ with EU safety, health, and environmental protection standards.
AiMIFY™ leverages advanced AI technology to amplify the contrast enhancement of brain MRI scans — up to twice the level typically achieved with a labeled dose of gadolinium-based contrast agents (GBCAs). This provides radiologists with improved contrast information – particularly aiding in the visualization of small and poorly enhanced lesions, which can be critical for the early detection and assessment of certain conditions. AiMIFY™ has demonstrated consistent efficacy across a wide range of validation data, including diverse patient demographics, pathologies, lesion sizes, scanner vendors, MRI sequences, and acquisition orientations.
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“We are proud to extend our successful partnership with Subtle Medical into the European market,” said Sascha Daeuber, Radiology Platform Leader at Bracco Imaging. “From the beginning, Subtle has proven to be an agile and visionary partner—our joint announcement of FDA clearance last year underscored that strength. With the CE Mark for AiMIFY, we’re taking the next step in our shared mission to deliver innovative, AI-powered solutions that enhance diagnostic precision and support radiologists and patients worldwide.”
“We’re thrilled to see AiMIFY™ achieve CE Marking, a milestone that validates the strength of our collaboration with Bracco Imaging and the clinical value of this breakthrough technology,” said Ajit Shankaranarayanan, PhD, Chief Product Officer at Subtle Medical. “AiMIFY™ represents a new frontier in AI-powered imaging—bringing enhanced clarity and confidence to brain MRI reads, without requiring changes to the standard of practice in contrast imaging. We’re excited to expand access to this innovation across Europe and continue advancing precision diagnostics for patients and radiologists alike.”
Source: PRNewswire
