FDA clears RadNet imaging AI solution for detecting neurodegenerative disease
The U.S. Food and Drug Administration recently cleared a new artificial intelligence solution from RadNet Inc. that helps radiologists detect signs of neurodegenerative disease.
Authorities granted 510(k) clearance for Brain Health in late September, with the Los Angeles-based imaging center operator touting the decision in a blog post Tuesday. The product helps with detecting and segmenting white matter hypersensitivities (WMH)—areas of increased brightness on MRI scans.
“By harnessing AI to analyze subtle patterns in brain imaging, this technology aims to enhance clinical review with automatic localization of WMH and precise boundary segmentation for accurate assessment,” Niccolo Stefani, RadNet’s business leader of population health and clinical AI, wrote Oct. 14.
Brain Health was manufactured by Dutch AI firm Quantib, which RadNet acquired in 2022, and will be distributed by DeepHealth (the company’s artificial intelligence division). It’s aimed at supporting objective assessment of MR images, also providing automatic analysis to track changes over time.
RadNet’s Neuro Suite of solutions also includes Brain Age, delivering AI-powered brain structure segmentations and volumetric measurements. The technology was built on FreeSurfer—an open source neuroimaging toolkit developed at the Athinoula A. Martinos Center for Biomedical Imaging, an affiliate of Mass General, Harvard and MIT, Stefani noted. Brain Age is designed to provide precise measures of both brain structure and intracranial volumes, lobes, hippocampus and bilateral subcortical structures. It also utilizes “smart” comparisons to a healthy reference database, highlighting deviations against prior scans for detecting disease progression, he added.
“The FDA clearance of Brain Health represents more than a regulatory milestone—it validates the belief that AI can transform the neurodegenerative disease care journey,” Stefani wrote. “Identifying signs of potential disease sooner means patients, families, and health systems can act more quickly, creating real impact at scale to advance population health. This aligns with our broader mission at DeepHealth: empowering breakthroughs in care through imaging.”
RadNet bills itself as the leading national provider of freestanding, fixed-site diagnostic imaging services in the U.S. based on number of locations (401) and annual imaging revenue (nearly $1.8B). The radiology services provider has been on an artificial intelligence buying binge of late, acquiring firms including See-Mode Technologies ($29M), iCAD ($103M), and DeepHealth ($44M), among others. It also earned another U.S. FDA clearance in August for a solution that allows off-site radiologic technologists to control scanners.
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.