Medtech company MRI2CT has received FDA 510(k) clearance for NextMR, an AI platform that creates 3D bone visualization of the lumbar spine and sacrum from a patient’s standard diagnostic MRI, according to an Oct. 7 news release.
The clearance moves MRI2CT toward MRI-only spine workflows. Surgeons can get detailed 3D bone anatomy for planning from the MRI the patient already had, with no separate imaging step and no added radiation exposure.
NextMR works with routine conventional MRI sequences acquired on 1.5T and 3T scanners and automatically generates its 3D bone output in under 60 seconds.
The platform was validated on an independent retrospective dataset of 145 adults with paired MRI and CT imaging from sites in the U.S. and Israel. It demonstrated submillimeter cortical delineation accuracy across multiple patient subgroups.
MRI2CT said NextMR images are not intended to replace CT imaging in general and that surgical decisions remain with the treating clinician.
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