FDA Clears Subtle Medical's AI-Powered Image Enhancement Software

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Subtle Medical today announced its artificial intelligence (AI)-powered image processing software, SubtleMR, received 510(k) clearance from the U.S. Food and Drug Administration (FDA).

SubtleMR uses deep learning algorithms, denoising and resolution enhancement to improve the image quality of existing scanners.

“We are pleased to received FDA clearance for SubtleMR, and we look forward to helping radiology departments and imaging centers get the most out of their existing MRI scanners,” said Enhao Gong, Ph.D., founder and CEO of Subtle Medical.

The software, which Subtle Medical said is compatible with any brand of MRI scanner and picture archiving and communication systems (PACS), could be beneficial for patients who have trouble staying still for long periods of time. Reducing the scan time for these patients not only improves the patient experience but could result in fewer artifact-ridden images and the need for physicians to re-scan an individual.

SubtleMR is currently in pilot clinical use at multiple university hospitals and imaging centers, Subtle Medical said.

“One of the most exciting things about deep-learning reconstruction is how it redefines the usual negotiation between exam time and image quality,” said Christopher Hess, M.D., chair of the radiology and biomedical imaging department at the University of California, San Francisco. “This could lead to significant downstream value for imaging operations and for patient experience.”

This is not Subtle Medical’s first AI-powered software to be cleared by the FDA.

In December, the company received clearance for SubtlePET, which allows hospitals and medical imaging centers to enhance images from up to four times faster PET scans.

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