AIRS Medical Receives FDA 510(k) Clearance for SwiftSight® Body Composition

AI-powered quantitative MRI solution enables imaging organizations to standardize body composition analysis, expand existing MRI services and create new revenue opportunities

CHICAGO, Oct. 5, 2026 /PRNewswire/ -- AIRS Medical today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for SwiftSight® Body Composition, expanding the company's quantitative MRI platform into body composition analysis. SimonMed Imaging will be the first customer to deploy the newly cleared solution.

SwiftSight Body Composition uses AI-powered MRI analysis to quantify muscle and adipose tissue from MR images, including visceral and subcutaneous fat, abdominal and thigh muscle, muscle quality and bilateral muscle balance, along with quantitative assessment of liver fat.

SwiftSight Body Composition is designed around a scan of less than five minutes, followed by automated AI analysis. AI-driven segmentation quantifies body composition measurements, which are benchmarked against age- and sex-matched reference populations. The resulting Body Composition Report brings together quantitative measurements, percentile rankings and visual summaries in one standardized view.

"Body composition becomes more meaningful when people can track change over time, and that requires an exam that is fast and practical to repeat," said Jina Park, Chief Strategy Officer at AIRS Medical. "That is why we built SwiftSight Body Composition around a scan of less than five minutes. Whether the goal is preventive health, weight management or longevity, we want people who are taking a more active role in their health to have a quantitative measurement they can return to over time."

A 5-Minute Workflow. Built for High Volume Imaging Centers

With an MRI scan of less than five minutes and an automated scan-to-report workflow, SwiftSight Body Composition is designed to fit into high-volume MRI operations while giving health systems and imaging networks a practical way to scale quantitative body composition across their existing MRI infrastructure. Organizations can add the service without introducing a separate imaging modality or building a new manual analysis workflow.

Automated AI analysis reduces the need for manual measurement, helping imaging organizations deploy the same quantitative body composition capability across multiple locations without adding unnecessary operational complexity. This supports a more consistent patient experience across the network, with the same approach to quantitative analysis and reporting regardless of where a patient is scanned, while also supporting continuity across locations and over time.

"The next phase of MRI is not just better images, but standardized quantitative information that can scale across an imaging organization," said Ajit Shankaranarayanan, PhD, Chief Product Officer at AIRS Medical. "SwiftSight Body Composition is part of that shift. By automating the analysis of muscle, adipose tissue and liver fat, we are making advanced quantitative assessment easier to integrate into routine MRI workflows and creating a foundation for additional measurement capabilities across the SwiftSight platform."

More Than Weight or BMI

Body weight and BMI cannot show how fat and muscle are distributed throughout the body. SwiftSight provides quantitative information about visceral and subcutaneous fat, muscle quantity and quality, bilateral muscle balance and liver fat, giving healthcare professionals a more detailed view of body composition.

The solution evaluates core muscles including the abdominal wall, psoas and paraspinal muscles, as well as the quadriceps, hamstrings and adductors, including assessment of muscle proportion, quality and bilateral balance.

Liver fat is quantified using proton density fat fraction (PDFF), with automated region-of-interest measurements and visual mapping. 

Supporting New MRI-Based Services

For imaging organizations, SwiftSight Body Composition also creates an opportunity to expand the value of existing MRI programs. Whole-body and preventive imaging, healthy-aging, weight-management and wellness programs can be extended with a differentiated quantitative service — creating a new revenue opportunity from MRI infrastructure already in operation.

Because MRI does not use ionizing radiation, SwiftSight can also support repeat quantitative assessment over time, allowing changes in body composition to be followed longitudinally. 

For multi-site organizations, the combination of automated analysis, structured reporting and quantitative benchmarking provides a foundation for delivering a more standardized body composition experience across locations.

Expanding the AIRS Medical MRI Intelligence Platform

FDA clearance of SwiftSight Body Composition represents another step in AIRS Medical's strategy to help radiologists and imaging organizations get more performance, consistency and intelligence from the MRI infrastructure they own.

SwiftSight Body Composition expands the company's quantitative MRI portfolio beyond brain imaging and advances a broader platform strategy spanning MRI acquisition, workflow automation, quantitative analysis and longitudinal measurement.

The SwiftSight roadmap is expected to continue expanding, with diffusion tensor imaging (DTI) planned for November 2026 and quantitative joint applications planned for 2027, extending the platform into additional areas of quantitative MRI.

About AIRS Medical

AIRS Medical is an MRI intelligence company helping radiologists and imaging organizations get more performance, consistency and intelligence from the MRI infrastructure they already own. Its portfolio includes SwiftMR®, AI-powered MRI reconstruction and workflow technology, and SwiftSight®, its quantitative MRI platform.

AIRS Medical solutions are used by healthcare organizations around the world to improve MRI performance and expand the value of existing imaging infrastructure.

For more information, visit airsmed.com.

Media Contact

Cynthia Ruffino
Vice President, Marketing
AIRS Medical
[email protected]

SOURCE AIRS Medical