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AIRS Medical announced on October 5, 2026, that the FDA granted 510(k) clearance to SwiftSight Body Composition, software the company says analyzes MRI images to quantify body fat, muscle, and liver fat. The announcement names SimonMed Imaging as the first customer expected to deploy it. The specific FDA filing and cleared labeling for this product were not established in the FDA records surfaced in the available search, so its features and clearance details below are attributed to AIRS Medical.
What SwiftSight Body Composition is designed to measure
AIRS Medical describes SwiftSight Body Composition as an AI analysis service that processes MRI images after a scan. The company says the software segments images and produces quantitative measurements, percentile rankings, and visual summaries benchmarked against age- and sex-matched reference populations. The listed measures include:
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- Visceral and subcutaneous fat.
- Abdominal and thigh muscle size, quality, and left-right balance.
- Liver fat, quantified using proton density fat fraction (PDFF).
AIRS Medical describes the MRI scan workflow as taking less than five minutes. That is the company’s stated intended workflow, not an independently verified performance figure. Its chief product officer, Ajit Shankaranarayanan, characterized the company’s broader strategy this way: “The next phase of MRI is not just better images, but standardized quantitative information that can scale across an imaging organization.”
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What FDA clearance means—and what remains unclear
AIRS Medical’s October 5, 2026 announcement is the direct source for the claim that SwiftSight Body Composition received FDA 510(k) clearance. The specific 510(k) number, FDA decision date, and cleared labeling for this product were not established by the FDA records surfaced in the available search. The records that did surface concern different AIRS Medical products: K261349 is for SwiftMR, and K251483 is for SwiftSight-Brain. Neither identifies the body-composition tool.
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That distinction matters: clearance of another product does not establish the body-composition software’s precise cleared indications or labeling. AIRS Medical’s product description is not, by itself, evidence that SwiftSight Body Composition diagnoses disease, improves health outcomes, or is validated as a screening test.
What is known about accuracy and reference comparisons
The company says the software compares measurements with age- and sex-matched reference populations, but the reviewed company materials do not establish the size or validation details of the body-composition reference population. They also do not provide independent clinical performance data or outcome evidence.
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AIRS Medical cited a normative database of 32,615 adults in a September 2026 update, but that figure belongs to SwiftSight-Brain—not SwiftSight Body Composition. It should not be treated as the size of the body-composition tool’s reference cohort.
Where it may be offered
AIRS Medical positions the software for imaging organizations and describes possible uses in preventive health, weight management, and longevity programs. It names SimonMed Imaging as the first customer expected to deploy SwiftSight Body Composition. The announcement does not specify rollout locations, public booking availability, prices, or referral requirements, so it does not establish that an individual can currently book this service at a nearby imaging center.
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