FDA clearance advances MRI-only spine workflows using the patient’s standard diagnostic MRI
CLAYMONT, Del. – October 7, 2026 – MRI2CT Inc. today announced FDA 510(k) clearance for NextMR, its AI powered imaging platform, for generating accurate 3D bone visualization of the lumbar spine and sacrum directly from a patient’s standard diagnostic MRI.
The clearance marks an important step toward MRI2CT’s vision of MRI-only workflows in spine care. Using the MRI already acquired as part of the patient’s diagnostic path, NextMR provides detailed 3D bone morphology without exposing the patient to additional radiation, creating a more streamlined pathway from initial imaging through surgical planning and execution.
“Patients commonly begin their spine journey with an MRI, while detailed 3D visualization of bone may require another imaging step,” said Shmulik Shpiro, CEO of MRI2CT. “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 conventional MRI sequences acquired on 1.5T and 3T scanners and automatically generates its 3D bone output in under 60 seconds. Clinicians can view the output in sagittal, coronal and axial planes and as a three dimensional reconstruction through the MRI2CT web interface or compatible DICOM environments. The secure, cloud-based application requires no local software installation.
“NextMR gives us the ability to take the routine MRI a patient already has and transition directly to highly accurate 3D bone morphology that can support the surgical workflow. That’s a huge advantage,” said Dr. Frank Phillips, Professor, Director, Section of Minimally Invasive Spine Surgery at Midwest Orthopaedics at Rush in Chicago. “For patients, that can mean avoiding additional imaging, radiation and appointments while helping streamline their path to surgery.”
NextMR was validated on an independent retrospective dataset of 145 adults with paired MRI and CT imaging from sites in the United States and Israel, demonstrating submillimeter cortical delineation accuracy across multiple patient subgroups.
About MRI2CT
MRI2CT is a medical technology company pioneering MRI-only workflows for orthopedic care. Its AI powered NextMR platform transforms standard diagnostic MRI into detailed 3D bone visualization, with a vision of connecting a single imaging exam to an increasingly streamlined pathway from imaging through planning and surgical enabling technologies. MRI2CT is headquartered in Claymont, Delaware. For more information, visit mri2ct.ai.
NOTE: NextMR Spine images are not intended to replace CT images in general. For use in subsequent workflows with third party devices, consult the documentation of the respective device(s) for compatibility. Clinical decisions regarding specific surgical procedures remain the responsibility of the qualified healthcare professional.