Subtle Medical secures CE Mark for SubtleHD

Mar 17, 2025

AI software developer Subtle Medical has secured the CE Mark, which allows it to market its SubtleHD platform in Europe.

SubtleHD offers radiologists, imaging centers, and hospitals a vendor-neutral AI tool that integrates with existing MRI scanners, thus allowing facilities to run faster scans and add additional patients while enhancing diagnostic confidence, according to the firm. It denoises and sharpens images and can be used with all body parts and all contrasts, including 2D and 3D images, Subtle Medical said.

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MRI scans show two areas of clinically significant prostate cancer in a 65-year-old man with a prostate-specific antigen level of 8.23 ng/mL. Images are (A, E) axial T2-weighted images, (B, F) axial diffusion-weighted images obtained with a b value of 1500 sec/mm2, (C, G) axial apparent diffusion coefficient images, and (D, H) lesion masks generated by the deep learning algorithm (DLA) on T2-weighted images. The DLA detected a lesion in the right posteromedial peripheral zone of the apex (D), which was assigned as Prostate Imaging Reporting and Data System (PI-RADS) 4. A radiologist also detected the lesion and assigned it PI-RADS 4 (arrow in A-C). A lesion in the right anterior transition zone (H) was detected by the DLA, which was assigned PI-RADS 4. The radiologist did not detect the lesion (arrow in E-G). Both lesions were confirmed as prostate cancer with Gleason grade group 2. Caption and image courtesy of RSNA.
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