FDA clears new software from Subtle Medical

Menlo Park, CA-based Subtle Medical has received U.S. Food and Drug Administration (FDA) clearance for SubtleSynth, AI software that uses deep learning to generate synthetic STIR images from already-acquired MRI T1- and T2-weighted contrasts.

SubtleSynth was validated for use in the spine and is complementary to Subtle's FDA-cleared and vendor-neutral SubtleMR software. SubtleSynth creates synthetic short tau inversion recovery (STIR) images with zero acquisition time that are interchangeable with conventionally acquired STIR images, the company said.

In addition, Subtle said it was recently awarded a $2.3 million Small Business Innovation Research grant from the National Institutes of Health to apply the SubtleSynth technology to brain and musculoskeletal imaging in future releases.

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