FDA clears AI tool that creates 3D bone visualizations from standard MRIs
The U.S. Food and Drug Administration has cleared an artificial intelligence-powered platform that can create 3D bone visualizations from standard spine MRIs.
Manufacturer MRI2CT Inc. touted the regulatory approval on Wednesday, with the decision applying to its NextMR product. The vendor said its goal is to enable “MRI-only workflows in spine care,” creating detailed models of bone morphology without the need to expose patients to additional radiation from CT.
MRI2CT, which is based in Israel, believes the product can create more streamlined pathways from imaging through surgical planning.
“Patients commonly begin their spine journey with an MRI, while detailed 3D visualization of bone may require another imaging step,” Shmulik Shpiro, CEO of MRI2CT, said in a statement Oct. 7. “NextMR changes that paradigm. Our vision is an MRI-only workflow that simplifies the patient journey and connects the standard diagnostic MRI more seamlessly with planning and surgical enabling technologies.”
NextMR works with routine MRI sequences acquired on 1.5T and 3T scanners. It automatically generates its 3D bone output in under 60 seconds, allowing providers to view the images through a web interface. The product was validated on an independent, retrospective dataset of 145 adults with paired MRI and CT images from sites in the U.S. and Israel.
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.