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Medical Devices / Submissions and Approvals

Subtle Medical’s Imaging Processor Cleared by FDA

Oct. 16, 2019

The FDA granted 510(k) clearance for Subtle Medical’s SubtleMR processing software that improves image quality.

The software uses proprietary deep learning algorithms to reconstruct images, using denoising and resolution enhancement to enrich image quality.

The software is particularly helpful for patients who have difficulty remaining still for long periods, which can lead to unclear images and the need for rescans, the company said.

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