Medtech firm Subtle Medical has received clearance from the U.S. Food and Drug Administration (FDA) for its AI-powered Subtle-HD MRI acceleration and enhancement software.
This clearance marks the launch of Subtle’s SubtleELITE suite of three AI-powered software tools: along with Subtle-HD, the suite includes SubtleSYNTH and SubtleALIGN, all collectively designed to work together to significantly both improve image quality and reduce MRI scan times, Subtle Medical said in a statement.
All three tools have now been cleared by the FDA, the company noted.
Subtle-HD, which is applicable to all regions of the body, uses advanced denoising and sharpening to produce images that often exceed the standard of care in quality, while enabling faster scans (up to 80% faster in some cases), according to the firm.
SubtleSYNTH is available for spine STIR, with expansion to other regions of the body underway. It uses deep learning to generate MR imaging contrasts from existing sequences, achieving 100% acceleration and producing STIR images in 0 minutes, Subtle Medical said.
SubtleALIGN, which currently supports 3D brain sequences, aligns brain MR images to the ideal anatomical position to improve consistency and reduce variability across longitudinal studies.
The SubtleELITE suite is compatible with all MRI scanners, the company said.