CLAYMONT, DE — MRI2CT Inc. has received U.S. Food and Drug Administration 510(k) clearance for an artificial intelligence imaging platform that generates three-dimensional bone images of the lower spine from conventional MRI scans, potentially reducing the need for additional CT imaging and radiation exposure during surgical planning.
The company’s NextMR platform converts standard diagnostic MRI data into detailed 3D visualizations of the lumbar spine and sacrum, allowing clinicians to evaluate bone structures without requiring a separate CT scan for that purpose.
The regulatory clearance establishes a pathway for MRI2CT to bring the technology into clinical use as the company pursues imaging workflows that rely on MRI rather than multiple scanning methods.
Patients undergoing evaluation for spinal conditions frequently receive MRI examinations to assess soft tissues, nerves and other structures. CT scans may subsequently be required to obtain detailed images of bone anatomy for surgical planning.
NextMR is designed to generate that bone information from MRI data already collected during the diagnostic process, potentially eliminating an additional imaging appointment in cases where its output meets clinical needs.
“Patients commonly begin their spine journey with an MRI, while detailed 3D visualization of bone may require another imaging step,” said Shmulik Shpiro, chief executive officer of MRI2CT.
“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,” Shpiro said.
The software works with conventional MRI sequences acquired on 1.5-tesla and 3-tesla scanners, two commonly used clinical MRI configurations.
According to MRI2CT, the platform automatically generates three-dimensional bone images in less than 60 seconds.
Clinicians can examine the resulting images in sagittal, coronal and axial planes, as well as through a three-dimensional reconstruction.
The images are accessible through MRI2CT’s web-based interface or compatible Digital Imaging and Communications in Medicine systems, allowing integration with existing medical imaging environments.
The cloud-based application does not require local software installation.
MRI2CT supported its regulatory submission with validation involving an independent retrospective dataset of 145 adults who had undergone both MRI and CT examinations at medical sites in the United States and Israel.
The company reported submillimeter accuracy in delineating cortical bone boundaries across multiple patient subgroups.
Those findings support the platform’s ability to reconstruct bone anatomy from MRI scans, although the reported validation concerns imaging accuracy rather than comparative surgical outcomes.
Dr. Frank Phillips, professor and director of minimally invasive spine surgery at Midwest Orthopaedics at Rush in Chicago, said the technology could simplify the transition from diagnostic imaging to surgical preparation.
“For patients, that can mean avoiding additional imaging, radiation and appointments while helping streamline their path to surgery,” Phillips said.
The clearance covers the platform’s generation of 3D bone visualizations of the lumbar spine and sacrum from standard MRI examinations.
For MRI2CT, the authorization represents a regulatory milestone in developing MRI-based alternatives to conventional workflows that use both MRI and CT imaging for spine evaluation and surgical planning.
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