FDA Clears MRI-Based AI Software for Body Composition Analysis

The Food and Drug Administration (FDA) has granted 510(k) clearance for SwiftSight Body Composition, an AI-enabled software that reportedly provides automated quantification of muscle and adipose tissue based on an MRI scan that takes less than five minutes.

Offering benchmarking against age- and sex-matched reference populations, the SwiftSight Body Composition software enables quantification assessments of visceral and subcutaneous fat, abdominal and thigh muscle, muscle quality and bilateral muscle balance, according to AIRS Medical, the developer of the software.

The company said the software provides clinicians with a standardized view of quantitative data, percentile rankings and visual summaries with the capability to provide longitudinal insights into changes with abdominal adiposity.

“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, the 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.”