NextMR, an AI imaging platform from MRI2CT, has won FDA 510(k) clearance to render the lumbar spine and sacrum in three dimensions using only a patient’s standard diagnostic MRI. The Claymont, Delaware, company says clinicians can now see detailed bone structure without ordering a second study.
For spine care that matters because the imaging pathway usually starts with an MRI, while a clear look at bone has traditionally meant an additional CT scan and another dose of radiation. NextMR is built to collapse those two steps into one, reusing the exam a patient has already had.
Under a minute
Routine sequences from 1.5T and 3T scanners are enough for the software, which assembles its 3D output in under 60 seconds. Sagittal, coronal and axial planes are available through a web interface or compatible DICOM viewers, along with a full three dimensional reconstruction. Nothing has to be installed locally; the application runs in the cloud.
An independent retrospective validation set of 145 adults, drawn from paired MRI and CT studies at sites in the United States and Israel, showed submillimeter cortical delineation accuracy across patient subgroups. Chief executive Shmulik Shpiro framed the ambition as an MRI-only workflow linking one exam to planning and surgical tools, and labeling cautions the images are not intended to replace CT generally.
