Subtle Medical Receives CE Mark for SubtleHD™ Software to Improve MRI Image Quality Across Europe

Subtle Medical, a global leader in AI-powered medical imaging enhancement, has announced CE Mark certification for SubtleHD™, its innovative software designed to dramatically improve MRI image quality, reduce scan times by up to 80%, and optimize radiology workflows. Now available in the European Union and other CE Mark-recognized regions, SubtleHD™ provides a vendor-neutral AI solution that integrates seamlessly with existing MRI scanners, enabling faster scans, increased patient throughput, and enhanced diagnostic confidence—all without costly hardware upgrades.

SubtleHD™ applies advanced denoising and sharpening techniques to produce ultra-clear images that often exceed standard-of-care quality. It is applicable to all body parts, contrasts, and imaging sequences, including 2D and 3D, with customizable settings for image quality and speed.

Key Benefits of SubtleHD™:

• Superior Image Quality: Significantly improved image quality enhances diagnostic confidence and speeds up radiology reads, particularly on older MRI scanners.
• Faster Imaging and Increased Revenue: Shorter scan times reduce patient wait times, keep technicians on schedule, and enable more daily scan slots without additional equipment investments.
• Improved Scanner Sustainability: Enhanced scanner performance extends the lifespan of existing MRI systems, allowing imaging centers to maximize their resources.
• Enhanced Patient Experience: Reduced scan times improve patient comfort and minimize motion-related artifacts, leading to fewer 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 best image enhancement solution for MRI. It unlocks unparalleled efficiency and image quality—helping radiologists read faster, reduce burnout, and improve patient care with existing resources.”

SubtleHD™ addresses critical challenges in European healthcare, where high demand, limited scanner availability, and workforce shortages often lead to long MRI wait times. By improving efficiency and image quality, SubtleHD™ empowers imaging centers to deliver better care while optimizing operational workflows.