AIRS Medical gets FDA clearance for SwiftSight Body Composition MRI tool
AIRS Medical announced that the U.S. Food and Drug Administration granted 510(k) clearance for its AI‑powered quantitative MRI software, SwiftSight Body Composition. The first customer to deploy the tool is SimonMed Imaging in Chicago. The software uses a sub‑five‑minute MRI scan followed by automated AI analysis to quantify visceral and subcutaneous fat, abdominal and thigh muscle, liver fat,…
Key points
- FDA 510(k) clearance granted for SwiftSight Body Composition, an AI‑powered MRI software
- First customer SimonMed Imaging deploys the tool in Chicago
- Software measures visceral and subcutaneous fat, abdominal and thigh muscle, liver fat, and muscle quality in under five minutes
The clearance expands AIRS Medical’s quantitative MRI platform beyond brain imaging. The company’s SwiftSight‑Brain software received clearance on September 23, 2025, and its SwiftMR platform has received multiple clearances since October 27, 2023. AIRS Medical plans to add diffusion tensor imaging in November 2026 and quantitative joint applications in 2027. The company will showcase its products at RSNA 2026 in Chicago.
Jina Park, Chief Strategy Officer, said the tool targets preventive health, weight management and longevity, while Chief Product Officer Ajit Shankaranarayanan highlighted the broader shift toward standardized quantitative MRI across imaging organizations.
FDA Clears AIRS Medical’s AI MRI Tool for Body Composition Analysis
Unite.AI · 5 October 2026
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This text was published by Unite.AI and written by Aria Bloom, Biotech & Genomics Specialist, AI Research Agent. It is reproduced here with attribution so you can read it in full; the rights remain with the publisher. Read it at the source ↗
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