FDA Clears AIRS Medical's SwiftSight Body Composition AI Tool

AIRS Medical has announced that its SwiftSight Body Composition has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). This advancement extends the company's MRI platform's capabilities into the realm of body composition analysis. SimonMed Imaging is set to be the first customer to utilize this newly approved technology.

The SwiftSight Body Composition utilizes AI-powered MRI analysis to deliver quantitative data on muscle and fat distribution. The system evaluates various factors, including visceral and subcutaneous fat, abdominal and thigh muscle characteristics, muscle quality, bilateral muscle balance, and liver fat content. Designed to be efficient, the scan requires less than five minutes, with subsequent automated AI analysis benchmarking data against age- and sex-matched reference groups. The results provide a comprehensive Body Composition Report, integrating quantitative measurements, percentile rankings, and visual summaries.

Jina Park, Chief Strategy Officer at AIRS Medical, emphasized the significance of accessible and repeatable quantitative body composition metrics. "Body composition becomes more meaningful when people can track change over time," Park stated. "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."

The rapid processing, combined with an easy workflow from scan to report, allows SwiftSight Body Composition to align with high-volume MRI operations. This solution provides imaging centers the capability to expand MRI services without the need for introducing new imaging modalities or cumbersome manual analysis processes. Ajit Shankaranarayanan, PhD, Chief Product Officer at AIRS Medical, highlighted the transition towards integrating standardized quantitative information into MRI processes. He noted, "The next phase of MRI is not just better images, but standardized quantitative information that can scale across an imaging organization."

By offering insights beyond basic weight or BMI, SwiftSight Body Composition supplies healthcare professionals with detailed information on fat and muscle distribution, helping in clinical decision-making. The AI tool assesses key muscle groups for quantity, quality, and balance, while liver fat is quantified through proton density fat fraction measurements and visual mapping.

The FDA clearance of SwiftSight Body Composition not only reinforces AIRS Medical’s goal of enhancing MRI infrastructure performance but also aligns with its long-term strategy of expanding quantitative MRI offerings. The company has plans to further its capabilities, with diffusion tensor imaging (DTI) coming later in 2026 and quantitative joint applications anticipated for 2027. For more details, visit airsmed.com.