Bracco Imaging and Subtle Medical announced that their AI-powered software, AiMIFY, has received the CE mark under the European Medical Device Regulation (MDR).
The software is designed to enhance magnetic resonance imaging (MRI) of the brain, and the CE mark confirms its compliance with EU safety, health, and environmental standards.
AiMIFY leverages advanced AI technology to enhance the contrast in brain MRI scans, achieving up to twice the contrast level typically obtained with standard gadolinium-based contrast agents (GBCAs).
The enhancement supports radiologists in the early detection and assessment of various conditions, particularly in visualising small and poorly enhanced lesions.
Bracco Imaging radiology platform leader Sascha Daeuber said: “We are proud to extend our successful partnership with Subtle Medical into the European market.
“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.”
The AiMIFY software has shown consistent efficacy across diverse validation data.
The data includes different patient demographics, pathologies, lesion sizes, scanner vendors, MRI sequences, and acquisition orientations.
Bracco Imaging and Subtle Medical are preparing for the commercialisation of AiMIFY in major European markets.
The phased rollout is anticipated to commence between late 2025 and early 2026, as the companies aim to bring the advanced technology to radiologists across Europe.
Based in Milan, Italy, Bracco Imaging is focused on prevention and precision diagnostic imaging and has a comprehensive portfolio across diagnostic imaging modalities.
The medical device company operates in over 100 markets worldwide, offering products for X-ray imaging, MRI, contrast-enhanced ultrasound (CEUS), and nuclear medicine.
Subtle Medical is an AI-powered medical imaging technology company that offers solutions that optimise radiology workflows, enhancing productivity and patient experience.
Subtle Medical chief product officer Ajit Shankaranarayanan said: “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.”
