Subtle Medical Nets FDA Clearance for AI-Powered MRI Acceleration and Enhancement Software

Subtle Medical announced the FDA clearance for SubtleHD, an MRI acceleration and enhancement software that uses advanced denoising and sharpening, producing ultra-clear images that often exceed standard-of-care quality. It also enables significantly faster scan protocols - some up to 80% - and is applicable to all body regions.

This approval marks the official launch of Subtle-ELITE, an AI-powered suite that includes three software tools: SubtleHD, SubtleSYNTH, and SubtleALIGN, all collectively designed to dramatically improve image quality and reduce MRI scan times with an 80% scan time reduction in certain sequences.

Compared with other image enhancement solutions, Subtle-ELITE drives greater value to radiologists and imaging institutions by combining three new tools into one package that optimizes the MRI workflow like never before.

"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, PhD, 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."