AIRS Medical Gets FDA Clearance for MRI Body Composition Tool
AIRS Medical said in a press release that the FDA granted 510(k) clearance for SwiftSight Body Composition on October 5. The AI software measures muscle, visceral and subcutaneous fat, muscle quality, muscle balance, and liver fat from MRI images.
The scan takes less than five minutes, followed by automated analysis and segmentation. The software compares measurements with reference populations matched by age and sex, then produces a report with measurements, percentile rankings, and visual summaries.
The system also evaluates abdominal and thigh muscles, including the psoas, quadriceps, hamstrings, and adductors. SimonMed Imaging will be the first customer to deploy the product.
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