12 hours ago
Bracco Imaging and Subtle Medical obtain CE mark for AI-powered MRI software
Italy-based Bracco Imaging and Subtle Medical have obtained an EU CE mark for AiMIFY, a jointly developed software designed to enhance the imaging of contrast MRI brain scans using artificial intelligence (AI).
Developed through the application of Bracco's imaging and Subtle's software, clinical evidence has demonstrated that AiMIFY provides contrast enhancement for MRI brain scans up to twice the level typically achieved with a labelled dose of gadolinium-based contrast agents (GBCAs).
Consequently, AiMIFY enhances the visualisation of small and poorly enhanced lesions that are critical to the early detection of certain conditions.
US-based Subtle Medical's chief product officer, Ajit Shankaranarayanan, points out that in achieving imaging enhancements in contrast MRI scans, whereby a contrast agent is administered to a patient before an MRI is undertaken, the software requires no adjustments to these standard practices.
According to the companies, validation data for AiMIFY, which was granted software as a medical device (SaMD) clearance from the US Food and Drug Administration (FDA) in October 2024, has demonstrated the technology's efficacy across diverse patient demographics, pathologies, lesion sizes, scanner vendors, MRI sequences, and acquisition orientations.
Radiology platform leader at Bracco Imaging, Sascha Daeuber commented: '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."
Bracco and Subtle Medical stated that they will now initiate commercialisation activities for AiMIFY in select European markets, with a phased commercial rollout expected between late 2025 and early 2026.
According to a 2023 report by GlobalData, the use of AI across healthcare is burgeoning, with the market forecast to reach a valuation of around $19bn by 2027. Radiology has emerged as one of the most common areas in which AI is being applied – as a means to drive efficiencies and alleviate clinician burnout.
In a recent report by KPMG on AI's impact on healthcare, 86% of healthcare professionals expressed their belief that AI adoption would give their organisation a competitive edge over those who did not.
"Bracco Imaging and Subtle Medical obtain CE mark for AI-powered MRI software" was originally created and published by Medical Device Network, a GlobalData owned brand.
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