Chicago, Illinois, U.S., October 6, 2026
AIRS Medical has announced that the U.S. Food and Drug Administration (FDA) granted 510(k) clearance for SwiftSight® Body Composition, expanding the company’s quantitative MRI platform into automated body composition analysis. The AI-powered solution is designed to help imaging organizations quantify muscle and adipose tissue from MRI scans, including visceral and subcutaneous fat, abdominal and thigh muscle, muscle quality, bilateral muscle balance, and liver fat. The newly cleared technology is intended to help imaging centers standardize quantitative body composition assessment while expanding the clinical and operational value of existing MRI infrastructure. SimonMed Imaging is expected to be the first customer to deploy the newly cleared solution.
AI-Powered MRI Delivers Quantitative Body Composition
SwiftSight Body Composition is designed around an MRI scan lasting less than five minutes, followed by automated artificial intelligence analysis. The technology uses AI-driven segmentation to quantify body composition measurements and benchmark results against age- and sex-matched reference populations. The resulting Body Composition Report combines quantitative measurements, percentile rankings, and visual summaries into a standardized format. By automating the analysis process, AIRS Medical aims to make advanced body composition assessment easier to incorporate into routine MRI workflows. The platform evaluates multiple clinically relevant measures, including visceral and subcutaneous adipose tissue, abdominal wall muscles, psoas and paraspinal muscles, quadriceps, hamstrings, and adductors. It also assesses muscle proportion, muscle quality, and bilateral muscle balance, providing information that cannot be captured through body weight or body mass index alone.
Five-Minute MRI Workflow Supports Imaging Centers
A key feature of SwiftSight Body Composition is its focus on high-volume imaging operations. With a scan time of less than five minutes and an automated scan-to-report workflow, the solution is designed to integrate quantitative body composition analysis into existing MRI infrastructure without requiring imaging organizations to introduce another imaging modality or establish a separate manual analysis process. AIRS Medical says the automated workflow can support a standardized approach across supported scanners and multiple imaging locations. This could help imaging networks provide a more consistent patient experience while enabling longitudinal tracking of body composition. Because MRI does not use ionizing radiation, repeat quantitative assessments can potentially be incorporated into programs where monitoring changes over time is important.
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Expanding MRI Services and Quantitative Imaging
The FDA clearance also positions SwiftSight Body Composition as a tool for imaging organizations seeking to expand MRI-based services. Applications may include preventive imaging, weight-management programs, healthy-aging initiatives, and wellness-focused services. By adding quantitative measurements of muscle, fat distribution, and liver fat to existing MRI workflows, organizations may be able to create additional services and revenue opportunities using infrastructure already in place. SwiftSight uses proton density fat fraction (PDFF) to quantify liver fat, incorporating automated region-of-interest measurements and visual mapping. AIRS Medical views the clearance as part of a broader strategy to increase the amount of standardized, quantitative information that can be extracted from MRI examinations. The company is also expanding its quantitative MRI roadmap, with diffusion tensor imaging (DTI) planned for November 2026 and quantitative joint applications planned for 2027. Together, these developments reflect the growing use of AI-powered analysis to transform MRI from primarily image-based diagnostics into a source of standardized quantitative measurements that can support clinical assessment and longitudinal monitoring.
Source: AIRS Medical press release
