FDA OKs Subtle Medical’s MRI Acceleration & Enhancement Software

Subtle Medical, a company specializing in artificial intelligence (AI)-powered medical imaging enhancement, has received U.S. Food and Drug Administration (FDA) clearance for SubtleHD, the company’s MRI acceleration and enhancement software.

The approval signals the launch of Subtle-ELITE an AI-powered suite that includes software tools SubtleHD, SubtleSYNTH, and SubtleALIGN. The three tools were designed to improve image quality and reduce MRI scan times, with 80% reduction in certain sequences.

SubtleHD uses advanced denoising and sharpening to produce clear images that often surpass standard-of-care quality, the company said. It can also enable significantly faster scan protocols and is applicable to all regions of the body.

SubtleSYNTH uses deep learning to create MR imaging contrasts from existing sequences, with 100% acceleration and generating STIR images in zero minutes.

SubtleALIGN automatically aligns brain MR to ideal anatomical position with more than 97% accuracy to reduce variability and improve consistency across longitudinal studies. It currently supports 3D brain sequences, with an option to generate orthogonal reformats.

Subtle Medical said it was the first to market with third-party, AI-powered image enhancement software solutions through the release of its SubtleMR and SubtlePET tools. These were deployed in over 16 countries across the world.

SubtleHD builds on this foundation, leveraging convolutional neural networks to provide sharper, clearer images with even greater time savings compared to SubtleMR.

“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. “By combining SubtleHD, SubtleSYNTH, and SubtleALIGN into a single, comprehensive package, Subtle-ELITE is setting a new benchmark for the future of MRI.”

At last year’s Radiological Society of North America (RSNA) meeting, Bayer announced a collaboration with Subtle Medical to develop investigational AI software in combination with an investigational lower contrast agent dose.