Claymont, Delaware, U.S., October 7, 2026
MRI2CT Inc., a medical technology company developing artificial intelligence solutions for orthopedic imaging, has announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its NextMR imaging platform. The AI-powered technology generates detailed three-dimensional (3D) bone visualizations of the lumbar spine and sacrum directly from standard diagnostic magnetic resonance imaging (MRI) scans. The clearance marks an important milestone in the company’s efforts to advance MRI-based workflows for spine care by reducing the need for additional imaging procedures in appropriate clinical settings. Traditionally, patients undergoing spine evaluation may receive an MRI to assess soft tissues and neurological structures, while detailed 3D visualization of bone may require a separate computed tomography (CT) scan. NextMR is designed to bridge this imaging gap by transforming conventional MRI data into detailed bone morphology that can support clinical assessment and surgical planning. According to MRI2CT, the platform works with routine MRI sequences acquired using 1.5-tesla and 3-tesla scanners and generates its output in under 60 seconds. The technology is intended to help streamline the patient journey while avoiding the additional radiation exposure associated with a separate CT scan when the generated visualization is appropriate for the intended workflow.
NextMR Converts Routine MRI Scans Into 3D Bone Images
NextMR uses artificial intelligence to generate 3D representations of the lumbar spine and sacrum from standard MRI scans, enabling clinicians to examine bone structures without requiring a dedicated CT acquisition for the specific visualization task. The platform automatically processes conventional MRI sequences and produces detailed outputs that can be viewed in sagittal, coronal and axial planes, as well as through a three-dimensional reconstruction. Clinicians can access the generated images through the MRI2CT web interface or compatible Digital Imaging and Communications in Medicine (DICOM) environments. The company states that its secure, cloud-based application does not require local software installation, potentially simplifying integration into existing imaging workflows. By using imaging already acquired during routine diagnostic evaluation, the technology aims to reduce additional steps between initial assessment and surgical planning. The platform generates its 3D bone output in less than 60 seconds, according to the company, offering a rapid processing workflow for clinical users. However, the manufacturer clarifies that NextMR images are not intended to replace CT images in general. Clinicians must consider the requirements of each procedure and the compatibility of any third-party devices used in subsequent workflows. Decisions regarding specific surgical interventions remain the responsibility of qualified healthcare professionals.
FDA Clearance Supported by MRI and CT Validation Data
MRI2CT reports that NextMR was evaluated using an independent retrospective dataset of 145 adults with paired MRI and CT imaging collected at sites in the United States and Israel. According to the company, the validation demonstrated submillimeter cortical delineation accuracy across multiple patient subgroups. Cortical delineation refers to identifying the outer boundary of bone, an important feature when developing detailed anatomical representations for orthopedic applications. The paired imaging dataset enabled the company to assess the AI-generated bone visualizations against corresponding CT images. These results support the technical development of NextMR, although the reported validation findings do not establish that the platform can replace CT for every diagnostic or surgical application. The FDA 510(k) clearance allows the device to be marketed for its cleared intended use, subject to applicable requirements. The clearance represents a regulatory milestone for MRI2CT as it advances its technology toward wider use in spine imaging workflows. Further real-world experience will help determine how the platform performs across different clinical environments and how effectively it integrates into existing planning processes.
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MRI2CT Advances MRI-Only Workflows for Spine Care
MRI2CT aims to simplify orthopedic care through AI-enabled MRI-only workflows, connecting routine diagnostic imaging with more detailed anatomical visualization. In spine care, reducing the need for additional imaging could potentially limit repeat appointments, lower cumulative radiation exposure from CT examinations and improve workflow efficiency for suitable patients. The company is developing NextMR as part of a broader vision to connect diagnostic imaging with surgical planning and enabling technologies. According to MRI2CT Chief Executive Officer Shmulik Shpiro, the platform is intended to make better use of MRI scans patients already receive and create a more streamlined pathway toward treatment. Clinical specialist Dr. Frank Phillips of Midwest Orthopaedics at Rush also highlighted the potential advantages of obtaining 3D bone morphology from existing MRI examinations. Nevertheless, the usefulness of AI-generated imaging depends on the clinical question, image quality, intended procedure and requirements of other medical devices. FDA clearance is an important step toward broader clinical adoption, but NextMR is not a universal substitute for CT imaging. The technology’s longer-term impact will depend on clinical implementation, appropriate use and evidence supporting its role in orthopedic workflows.
Source: MRI2CT press release
