Subtle Medical’s SubtleHD™ Receives CE Mark, Expanding Access to AI-Powered MRI Enhancement Across Europe

SubtleHD sets a new benchmark in image quality and speed for European MRI providers.

MENLO PARK, Calif., March 17, 2025 /PRNewswire/ — 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.”

Join us for a live webinar hosted by AuntMinnie.com on March 19, 2025, at 10 AM PT / 1 PM ET to hear how leading institutions are leveraging SubtleHD™ to redefine MRI imaging.  Register Now

About Subtle Medical

Subtle Medical is a leading provider of AI-powered imaging solutions, optimizing scan efficiency and image quality across radiology. Recognized as a CB Insights GenAI 50 company and a two-time CB Insights Top AI 100 and Digital Health 150 company, Subtle Medical is committed to driving innovation in medical imaging. Deployed globally across 900+ scanners worldwide, Subtle Medical’s solutions help imaging centers and hospitals improve workflow efficiency, increase scanner sustainability, and elevate patient care.  Learn more and request a demo at www.subtlemedical.com.

Media Contact:

Anna Menyhart-Borroni
Head of Global Marketing
anna@subtlemedical.com

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SOURCE Subtle Medical, Inc.