Silicon Valley tech company gains FDA approval for AI-powered image cleanup tool

Menlo Park, California-based Subtle Medical announced Tuesday, Oct. 15, that it’s the first to score FDA approval for an AI-fueled technology to enhance MRI images.

SubtleMR, as the product is called, is an image-processing software that deploys deep-learning algorithms to bolster images created by any scanner. Currently, several imaging centers and universities, including the University of California, San Francisco, are testing it for clinical use, according to a company announcement.

"One of the most exciting things about deep-learning reconstruction is how it redefines the usual negotiation between exam time and image quality. This could lead to significant downstream value for imaging operations and for patient experience," Christopher Hess, MD, chair of the Department of Radiology and Biomedical Imaging at UCSF, said in a statement.

The AI-powered technology can be integrated with any brand of MRI or picture archiving and communication system. And it can prove useful for imaging patients who have a hard time sitting still for long stretches of time, eliminating the need for costly and time-consuming re-scans.

Subtle Medical said that it is first and only company to receive FDA clearance for technology that uses artificial intelligence to enhance medical images. Last year, the Food and Drug Administration also approved its SubtlePET, which helps to enhance pictures produced by positron-emission tomography.

Subtle CEO and founder Enhao Gong called this week’s news an “important milestone for the company.”