Subtle Medical has received FDA clearance for its Subtle-HD software, a tool designed to improve MR image quality while reducing scan times.

The Menlo Park, California-based company is launching Subtle-ELITE, a suite that includes SubtleHD along with two other AI-powered tools: SubtleSYNTH and SubtleALIGN.

According to Subtle Medical, SubtleHD enhances MR images using advanced denoising and sharpening techniques. The company says the software can reduce scan times by up to 80% in certain sequences while maintaining or improving image quality.
SubtleSYNTH uses deep learning to generate synthetic MR image contrasts from existing sequences, eliminating the need for additional scan time. Initially available for spine STIR imaging, the company plans to expand its application to other body regions.

SubtleALIGN is designed to automatically align brain MR images to an ideal anatomical position, improving consistency in longitudinal studies. The company reports the software achieves over 97% accuracy in alignment and currently supports 3D brain sequences.

"The FDA clearance of Subtle-HD marks a significant milestone in AI-driven radiology, giving hospitals and imaging centers a powerful solution to increase efficiency, improve image quality, and optimize workflows — all without additional hardware costs," said Ajit Shankaranarayanan, Ph.D., chief product officer at Subtle Medical.

Subtle Medical, known for its AI-powered imaging enhancement tools, previously introduced SubtleMR and SubtlePET, which are deployed in more than 16 countries. The company emphasizes that its latest offerings are compatible with all MR scanners, regardless of manufacturer, allowing facilities to optimize their existing equipment without major capital investments.

Artificial Intelligence Homepage