Subtle Medical has received U.S. Food and Drug Administration (FDA) clearance for version 2.0 of its SubtleMR software for enhancing MR images.
The vendor-neutral software is a virtual upgrade to existing MRI machines that can boost scanner performance across the entire fleet. The upgrade increases image sharpness for head MRI and can now be used to reduce image noise for the entire body, including but not limited to the head, spine, neck, abdomen, pelvis, prostate, breast, and musculoskeletal regions of the body.
The company received FDA clearance for the initial version of SubtleMR in 2019.
In addition, the company said it is currently testing a product called SubtleGAD, a software application it hopes may be able to significantly reduce gadolinium dose by 90% during imaging procedures while maintaining high-quality diagnostic MRI images.
