FDA clears AI solution for aiding with MRI body-composition assessments
The U.S. Food and Drug Administration has green-lit an artificial intelligence-powered solution for aiding radiologists with MRI body-composition assessments.
Manufacturer AIRS Medical announced the news on Monday, with the 510(k) clearance applying to its SwiftSight Body Composition offering. The software analyzes MR images to help quantify muscle and tissue, including visceral and subcutaneous fat.
AIRS Medical, which is based in Seoul, said the software is designed around a scan of less than five minutes, followed by an automated AI analysis. AI-powered segmentation quantifies body composition measurements, producing a final report that brings together this data and helps docs compare it against a reference population.
“Body composition becomes more meaningful when people can track change over time, and that requires an exam that is fast and practical to repeat,” Jina Park, chief strategy officer at AIRS Medical, said in a statement Oct. 5. “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.”
Park and colleagues said the product is designed to fit into high-volume MRI operations, granting a practical means to scale these body assessments across existing infrastructure. AIRS Medical highlighted the growing popularity of whole-body and other preventive imaging, weight management and wellness programs. It believes the software can help create a “new revenue opportunity” with MRI technology that is already used in most imaging centers. Scottsdale, Arizona-headquartered radiology group SimonMed Imaging—which has its own whole-body MRI program—will be the first to deploy the newly cleared solution in the U.S.
The news comes after AIRS Medical recently scored private equity backing from TA Associates in June. Founded in 2018, AIRS also provides other deep-learning solutions including its flagship SwiftMR, which reduces scan times while boosting image quality.
Marty Stempniak has covered healthcare since 2012, with his byline appearing in the American Hospital Association's member magazine, Modern Healthcare and McKnight's. Prior to that, he wrote about village government and local business for his hometown newspaper in Oak Park, Illinois. He won a Peter Lisagor and Gold EXCEL awards in 2017 for his coverage of the opioid epidemic.