AIRS Medical Gets FDA Clearance for SwiftSight Body Composition MRI Software

AIRS Medical said on Monday that it has received FDA 510(k) clearance for SwiftSight Body Composition, software that uses artificial intelligence to measure fat and muscle from MRI scans, according to a company press release. The clearance extends the company's quantitative MRI platform, SwiftSight, into body composition analysis.

The company said the software is built around an MRI scan of less than five minutes, followed by automated AI analysis. SimonMed Imaging will be the first organization to deploy the cleared product, AIRS said. The release did not give a 510(k) number or a decision date.

What the software measures

According to AIRS, SwiftSight Body Composition segments MR images to quantify:

• visceral and subcutaneous fat;
• abdominal and thigh muscle, including muscle quality and the balance between left and right sides;
• liver fat, measured as proton density fat fraction (PDFF).

The software evaluates core muscles, including the abdominal wall, psoas and paraspinal muscles, as well as the quadriceps, hamstrings and adductors, the company said. Results are compared with age- and sex-matched reference populations and presented in a single Body Composition Report with measurements, percentile rankings and visual summaries.

"That is why we built SwiftSight Body Composition around a scan of less than five minutes," Jina Park, AIRS Medical's chief strategy officer, said in the release, after describing the value of tracking body composition over time. Ajit Shankaranarayanan, the company's chief product officer, said in the release that the next phase of MRI is standardized quantitative information rather than better images alone.

Company and roadmap

AIRS Medical describes itself as an MRI intelligence company. Its portfolio includes SwiftMR, AI-powered MRI reconstruction and workflow software, and the SwiftSight quantitative platform, which the company first introduced with a brain application.

The company said it plans to add diffusion tensor imaging (DTI) to the platform in November 2026 and quantitative joint applications in 2027. Applied Radiology, which published the announcement on October 6, reported the same roadmap and SimonMed as the first customer.

AuntMinnie reported that AIRS is aiming the product at whole-body and preventive imaging, weight-management and wellness programs, and repeat assessments of the same patient over time.

The new clearance follows an April 2026 FDA clearance that allows SwiftMR to run alongside the AI deep-learning reconstruction pipelines supplied by scanner manufacturers, AuntMinnie reported at the time. In that report, AIRS said SwiftMR was in use at more than 1,700 imaging centers and hospitals in more than 40 countries, and cited an example in which a routine brain scan on a GE HealthCare 3T system fell from 15 to 9 minutes.

AIRS did not disclose pricing or commercial terms for SwiftSight Body Composition, and the release did not describe the clinical validation data submitted to the FDA.

AIRS framed its product as a way for imaging providers to get more use from MRI equipment they already own, according to the release.