AIRS Medical announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for SwiftSight Body Composition, expanding the company’s quantitative MRI platform into body composition analysis. SimonMed Imaging will be the first customer to deploy the newly cleared solution.
SwiftSight Body Composition uses AI-powered MRI analysis to quantify muscle and adipose tissue from MR images, including visceral and subcutaneous fat, abdominal and thigh muscle, muscle quality and bilateral muscle balance, along with quantitative assessment of liver fat.
SwiftSight Body Composition is designed around a scan of less than five minutes, followed by automated AI analysis. AI-driven segmentation quantifies body composition measurements, which are benchmarked against age- and sex-matched reference populations. The resulting Body Composition Report brings together quantitative measurements, percentile rankings and visual summaries in one standardized view.