FDA Clears First Dental-Dedicated MRI with Under-20-Minute Workflow
Magnetom Free.Max Dental Edition, the first dental-dedicated MRI system developed by Dentsply Sirona and Siemens Healthineers, received FDA clearance after a clinical trial validating its use across endodontics, periodontics, TMJ, tooth extraction and orthodontics. The system offers a dedicated dental field of view, non-ionizing imaging and under-20-minute workflow efficiency.
1. FDA Clearance and Trial Validation
MAGNETOM Free.Max Dental Edition received FDA clearance in the United States following a clinical trial that validated its diagnostic potential across multiple dental specialties, including endodontics, periodontics, TMJ evaluation, tooth extraction and orthodontics.
2. Specialized Imaging Features and Workflow
The system features a dedicated dental coil and software that focus exclusively on dental structures, providing a dental-specific field of view without brain tissue visualization and maintaining an average clinical workflow time of under 20 minutes.
3. Clinical Applications and Diagnostic Benefits
Clinical highlights showed the MRI’s ability to differentiate active inflammation from healthy or scar tissue, assess tooth pulp vitality non-invasively, and visualize tooth positioning relative to nerves, enhancing diagnostic confidence in areas where ionizing modalities have limitations.
4. Training and Upcoming Demonstrations
An advanced hands-on training program is scheduled for April 2026 at the University of Minnesota, and clinicians will have the opportunity to see live demonstrations at the ADEA Annual Session in Montréal, emphasizing readiness for hospital, clinic and academic adoption.