MRI2CT gets FDA clearance for MRI-based spine imaging software

Claymont, DE-based imaging software developer MRI2CT has secured U.S. Food and Drug Administration (FDA) 510(k) clearance for AI software that generates 3D bone visualizations of the lumbar spine and sacrum from MRI scans. 

NextMR works with conventional MRI sequences from 1.5-tesla and 3-tesla scanners and produces its 3D bone output in under 60 seconds, according to the company. Clinicians can view the output in sagittal, coronal, and axial planes and as a 3D reconstruction, through the company's web interface or in compatible DICOM environments. The software runs in the cloud and requires no local installation, MRI2CT said.

The software was validated on an independent retrospective dataset of 145 adults with paired MRI and CT scans from sites in the U.S. and Israel. It showed submillimeter accuracy in outlining cortical bone, the firm said.