FDA clears AIRS Medical's AI MRI tool for body composition analysis
AIRS Medical said on October 5, 2026, that the FDA granted 510(k) clearance for SwiftSight Body Composition, its AI-powered quantitative MRI software, with SimonMed Imaging as the first customer. The scan takes under five minutes and analysis is fully automated.
- FDA granted 510(k) clearance for SwiftSight Body Composition on October 5, 2026
- Scan takes under five minutes with fully automated AI analysis
- Software quantifies visceral and subcutaneous fat, abdominal and thigh muscle, and liver fat via PDFF
- SimonMed Imaging is the first customer; products to be shown at RSNA 2026 in Chicago
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