Subtle Medical’s AI-Powered SubtleHD™ Secures CE Mark, Bringing Faster, Higher-Quality MRI Imaging to Europe

Subtle Medical, a global leader in AI-powered medical imaging enhancement, announced today that SubtleHD™ has received CE Mark certification, officially launching the solution in Europe. The software is designed to dramatically improve MRI image quality, reduce scan times by up to 80%, and optimize radiology workflows.

Many European countries face significant MRI wait times due to a combination of high demand, insufficient scanner availability and workforce shortages. Now available in the European Union and other CE Mark-recognized regions, SubtleHD™ provides radiologists, imaging centers, and hospitals with a vendor-neutral AI solution that integrates seamlessly with existing MRI scanners, allowing facilities to run faster scans and add additional patients, while enhancing diagnostic confidence—without requiring costly hardware upgrades.

SubtleHD™ applies advanced denoising and sharpening to produce ultra-clear images that often exceed standard-of-care quality while enabling up to 80% faster scans on some sequences. It's applicable to all body parts, all contrasts, including 2D and 3D, and includes customizability for image quality and speed.

SubtleHD™ provides imaging institutions:

• Superior Image Quality - Significantly improved image quality allows for greater diagnostic confidence and faster reads, especially on older magnets struggling with image quality.
• Faster Imaging; Increased Revenue– Shorter scan times keep techs on schedule, reduce patient wait times, and enable more daily scan slots without additional equipment investments.
• Improved Scanner Sustainability – Upgraded scanner performance extends the lifespan of existing MRI scanners and enables centers to do more with existing resources.
• Enhanced Patient Experience – Shorter scan times improve patient comfort and can help with fewer motion-related artifacts and rescans.

"Receiving CE Mark for SubtleHD™ marks a major step in expanding access to higher quality MRI imaging across Europe," said Josh Gurewitz, Chief Commercial Officer at  Subtle Medical. "With SubtleHD™, hospitals and imaging centers now have the newest and by far the best image enhancement solution for MRI to hit the market. It unlocks unparalleled efficiency and image quality—helping radiologists read faster, reduce burnout, and improve patient care with existing resources."