Bracco Imaging and Subtle Medical Secure CE Mark for AiMIFY™ MRI Software in Europe

Bracco Imaging S.p.A., a global leader in diagnostic imaging, and Subtle Medical, Inc., an AI-driven imaging technology firm, have jointly announced that their software AiMIFY™ has received CE Mark certification under the European Medical Device Regulation (MDR). This regulatory approval affirms that AiMIFY™ complies with the EU’s standards for safety, health, and environmental protection.

AiMIFY™ is an artificial intelligence-powered tool designed to enhance contrast in brain MRI scans. It can amplify contrast enhancement by up to two times the usual level achieved with standard doses of gadolinium-based contrast agents (GBCAs). This improvement allows radiologists to better visualize small or minimally enhanced lesions—an essential capability for early diagnosis and clinical assessment. The software has demonstrated robust performance across diverse clinical variables, including patient demographics, pathologies, lesion characteristics, MRI hardware vendors, scanning orientations, and sequence types.

"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."

Ajit Shankaranarayanan, PhD, Chief Product Officer at Subtle Medical, emphasized the importance of the milestone: "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. 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."

Following CE Mark approval, Bracco and Subtle Medical are preparing to launch AiMIFY™ commercially across key European regions. The phased rollout is scheduled to begin in late 2025 and extend into early 2026.

To further spotlight the innovation, Applied Radiology will host a webinar tomorrow featuring expert commentary from both Bracco Imaging and Subtle Medical. The session will also be available for on-demand viewing.

AiMIFY™ is produced for Bracco Imaging by Subtle Medical Inc., headquartered in Menlo Park, California. The AiMIFY™ name is a registered trademark of Bracco Imaging S.p.A.