AIRS Medical gains FDA clearance for SwiftSight Body Composition MRI tool

AIRS Medical received FDA 510(k) clearance for SwiftSight Body Composition, an AI-powered quantitative MRI software that measures visceral and subcutaneous fat, abdominal and thigh muscle, liver fat, and muscle quality from a scan that takes under five minutes. The first clinical deployment is already underway at SimonMed Imaging in Chicago, signaling immediate commercial traction for a tool aimed squarely at preventive health and longevity medicine.

What the software measures

SwiftSight Body Composition automates the analysis of body composition metrics that traditionally require manual segmentation or separate imaging protocols. The software quantifies five specific areas: visceral fat, subcutaneous fat, abdominal muscle, thigh muscle, and liver fat. It also assesses muscle quality, a metric linked to metabolic health and age-related decline. The entire process - scan plus AI analysis - completes in under five minutes.

The clearance broadens AIRS Medical's regulatory footprint beyond neuroimaging. The company's SwiftSight-Brain software received FDA clearance on September 23, 2025, and its SwiftMR platform has collected multiple clearances since October 27, 2023. The product roadmap includes diffusion tensor imaging capabilities in November 2026 and quantitative joint applications in 2027. AIRS Medical plans to showcase its full product line at RSNA 2026 in Chicago.

Clinical deployment and market positioning

SimonMed Imaging, one of the largest outpatient imaging networks in the United States, is the first customer to deploy the software. The partnership places SwiftSight Body Composition in a high-volume clinical setting where preventive screening programs already operate.

Jina Park, Chief Strategy Officer at AIRS Medical, said the tool targets "preventive health, weight management and longevity." Ajit Shankaranarayanan, Chief Product Officer, highlighted "the broader shift toward standardized quantitative MRI across imaging organizations." Both comments point to a strategy built on replacing qualitative radiology reads with reproducible numeric outputs.

Why this matters for healthcare and product development professionals

For imaging product developers, the clearance demonstrates a regulatory pathway for AI-driven quantitative MRI tools that go beyond diagnostic radiology into wellness and metabolic health. The sub-five-minute scan time addresses throughput concerns that have historically limited MRI's role in preventive screening. For clinical researchers, standardized body composition metrics from routine MRI scans create new endpoints for obesity, metabolic, and aging studies. For healthcare operations leaders, the SimonMed deployment offers an early case study in integrating automated quantification into existing imaging workflows without adding technologist burden.