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AIRS Medical Secures FDA Clearance for AI-Driven MRI Body Analysis

The U.S. Food and Drug Administration has granted 510(k) clearance to AIRS Medical for its SwiftSight Body Composition platform. By automating the quantification of muscle and adipose tissue through five-minute MRI scans, the technology allows imaging centers to offer standardized metabolic health assessments without requiring new hardware.

Bio & NewsOctober 5, 2026582 reads0

SimonMed Imaging will serve as the first partner to integrate the solution, which moves beyond traditional BMI metrics to provide granular data on visceral and subcutaneous fat, muscle quality, and liver fat levels. The platform uses AI-driven segmentation to benchmark patient data against age- and sex-matched reference populations, delivering a standardized report that simplifies longitudinal tracking for preventive care and weight management programs.

Designed for high-volume environments, the software automates the analysis process to remove manual measurement bottlenecks. This allows healthcare networks to maintain consistent diagnostic standards across multiple locations while leveraging existing MRI infrastructure. Beyond the current body composition capabilities, AIRS Medical plans to expand the SwiftSight platform with upcoming modules for diffusion tensor imaging and joint analysis, furthering its push to transform standard MRI machines into advanced quantitative diagnostic tools.

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