Subtle Medical gets FDA nod for SubtleMR

By staff writers

October 15, 2019 -- Imaging artificial intelligence software developer Subtle Medical has garnered U.S. Food and Drug Administration (FDA) 510(k) clearance for its SubtleMR image-processing software.

Compatible with any brand of MRI scanner and PACS software, the deep learning-based application is designed to use denoising and resolution enhancement to improve MR image quality, according to the firm. It has currently been placed in pilot clinical use at multiple university hospitals and imaging centers, Subtle Medical said.

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