AIRS Medical reports FDA clearance for AI-based MRI body-composition analysis
Published in Artificial Intelligence, Scanners and Imaging, Tools.
Published October 5, 2026. Source date: October 5, 2026.
AIRS Medical announced U.S. FDA 510(k) clearance for SwiftSight Body Composition, its AI-powered quantitative MRI software. SimonMed Imaging is named as the first customer scheduled to deploy the solution.
The software measures muscle and adipose tissue, including visceral and subcutaneous fat, abdominal and thigh muscle, muscle quality and left–right balance. It also provides quantitative liver-fat assessment.
According to AIRS Medical, the workflow uses an MRI scan lasting less than five minutes followed by automated segmentation. A standardized report combines measurements, percentile comparisons against age- and sex-matched reference populations, and visual summaries.
The announcement expands the company’s quantitative MRI platform beyond brain imaging. The scan duration and workflow descriptions are company-reported. Clearance does not itself establish that preventive scanning improves long-term health outcomes, and this U.S. announcement does not confirm Canadian authorization or availability.