First-ever Dental Dedicated MRI Validated in Clinical Trial and Cleared by FDA for Advanced Soft-Tissue Diagnostics
MWN-AI** Summary
Dentsply Sirona and Siemens Healthineers have attained a significant breakthrough in dental imaging with the FDA clearance of the MAGNETOM Free.Max Dental Edition, the first-ever dental-dedicated MRI (ddMRI) system. This milestone is rooted in a successful clinical trial that underscored the system's vast potential across various dental specialties including endodontics, periodontics, and TMJ disorders. Notably, the ddMRI offers non-ionizing imaging, enhancing both diagnosis and treatment planning by highlighting critical soft tissue details without exposing patients to harmful radiation.
The clinical trial revealed that the MAGNETOM Free.Max Dental Edition excels in differentiating between active inflammation and healthy or scar tissue, as well as providing non-invasive assessments of tooth pulp vitality. Its specialized features, such as a dental-specific field of view enabled by tailored software and dedicated dental coils, ensure focused imaging on dental structures while minimizing visibility of irrelevant brain tissue. The system's efficiency is further illustrated by an average workflow time of less than 20 minutes, making it a valuable addition to clinical practices.
The launch of this pioneering ddMRI system complements existing imaging technologies like intraoral and CBCT by addressing areas where soft tissue characterization is paramount. Dentsply Sirona's President, Dan Scavilla, hailed this innovation as a powerful enhancement to current diagnostic capabilities, while Andreas Schneck from Siemens Healthineers emphasized the necessity of expanding MRI's clinical impact in dentistry.
To facilitate the adoption of ddMRI into clinical practice, an advanced training program is scheduled for April 2026 at the University of Minnesota, focusing on essential imaging protocols and patient safety. The unveiling of this cutting-edge technology will be showcased at the upcoming American Dental Education Association Annual Session in March 2026, marking a transformative step forward in dental diagnostics.
MWN-AI** Analysis
The recent FDA clearance of the MAGNETOM Free.Max Dental Edition, the first dental-dedicated MRI (ddMRI) system developed by Dentsply Sirona and Siemens Healthineers, marks a pivotal advancement in dental diagnostic imaging. This technology promises enhanced soft-tissue imaging capabilities without the risks associated with ionizing radiation, positioning it as a superior alternative to conventional imaging modalities such as intraoral, panoramic, and cone beam computed tomography (CBCT).
As an astute financial analyst, now is an opportune moment to consider the investment potential of Dentsply Sirona. With the ddMRI’s clinical trial validating its utility across multiple dental specialties—such as endodontics, periodontics, and orthodontics—this product could drive significant revenues and capture market share in a growing sector. Dental practices are increasingly prioritizing advanced diagnostics, and the ddMRI serves a critical need for non-invasive imaging in areas that require superior soft tissue contrast.
Moreover, the system's streamlined workflow—with an average patient preparation time under 20 minutes—enhances operational efficiency, appealing to dental institutions looking to optimize patient throughput. Given that hospitals and large clinics represent the primary market for this technology, widespread adoption could sharply increase Dentsply Sirona's top-line growth and solidify its leadership position in dental innovations.
Investors should keep an eye on the company’s performance metrics post-launch. Understanding how quickly clinics adopt this technology will be crucial. In addition, as training programs commence, there is potential for enhanced market penetration, which could reflect positively in revenue reports.
In conclusion, Dentsply Sirona's strategic entry into advanced dental imaging with a robustly validated product offers promising prospects for discerning investors willing to capitalize on innovations that redefine patient care in the dental industry. Consider monitoring market reactions and clinical uptake for informed investment decisions.
**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.
Dentsply Sirona and Siemens Healthineers are pleased to announce that the first-ever dental-dedicated MRI1 (ddMRI) system – MAGNETOM Free.Max Dental Edition – has received FDA clearance in the United States. This milestone follows the completion of a clinical trial2 validating the system’s significant potential across multiple dental specialties. The trial highlighted this first-of-its-kind technology’s applicability in endodontics, periodontics, TMJ, tooth extraction, and orthodontics, offering non-ionizing imaging capabilities that can enhance diagnosis and treatment planning.
CHARLOTTE, N.C., March 09, 2026 (GLOBE NEWSWIRE) -- Dentsply Sirona and Siemens Healthineers are pleased to share key findings from the clinical trial for validation of their dental-dedicated MRI system. In addition to confirming its significant potential across multiple dental specialties, the trial also underscored the ddMRI system’s specialized features designed to meet the unique needs of dental professionals. Among these features is a dental-specific field of view, enabled by a dedicated dental coil and specialized software that focuses exclusively on dental structures, ensuring no brain tissue is visible and allowing for accurate imaging of dental structures. Additionally, the system’s ability to streamline patient preparation and maintain an average workflow time of under 20 minutes3 makes it a highly efficient tool for clinical use.
Clinical highlights from the trial demonstrated MAGNETOM Free.Max Dental Edition’s ability to differentiate active inflammation from healthy and scar tissue, enable non-invasive assessment of tooth pulp vitality to support chairside testing and observations and enables the visualization of teeth and their position in relation to neighboring teeth as well as the nerves.
“MAGNETOM Free.Max Dental Edition represents a significant advancement in dental imaging, providing excellent insights into dental structures that were not readily visible in other imaging modalities, without the risks associated with ionizing radiation. The ability to observe the same region of interest employing different ddMRI imaging sequences provides significantly more information regarding the pathological processes in hard and soft tissues which results in a more accurate understanding of the lesion. This capacity to see the clarity of the soft tissue detail produced by ddMRI has clear potential to enhance diagnostic confidence in areas where current modalities have limitations,” said Prof. Don Tyndall, DDS, MSPH, PhD, FICD, FACD; Diplomate ABOMR, Professor of Diagnostic Sciences at University of North Carolina, who reviewed the clinical trial findings and collaborated in the FDA clearance process.
Dental-dedicated MRI: excellent complement to existing imaging solutions
As an ionizing radiation-free modality with advanced soft tissue contrast, ddMRI complements intraoral, panoramic, and CBCT imaging by addressing diagnostic questions where soft tissue characterization is critical.
MAGNETOM Free.Max Dental Edition, the first-of-its-kind dental-dedicated MRI, was developed jointly by Dentsply Sirona, Siemens Healthineers, and leading scientists in Europe and the United States. Specifically designed to enhance dentomaxillofacial diagnostics, ddMRI is primarily intended for hospitals, large clinics, and universities, and offers advanced soft tissue contrast through ionizing radiation-free imaging.
“This innovation is a powerful addition to our imaging portfolio, which includes Axeos, Orthophos SL, and Heliodent Plus, among others. We’re proud to have contributed to developing the industry’s first dental dedicated MRI and the advancement of diagnostic capabilities in the field,” observed Dan Scavilla, President & CEO of Dentsply Sirona.
“We are dedicated to expanding the clinical impact and reach of MRI. We are excited to see the potential of ddMRI being validated through clinical trials, which will pave the way for a new clinical field that will benefit dental practitioners and patients alike,” said Andreas Schneck, head of Magnetic Resonance at Siemens Healthineers.
Advanced Clinical Training Opportunity
Clinicians interested in incorporating ddMRI into their practice can participate in an advanced, hands?on training program taking place in April 2026 at the University of Minnesota. This two?day course covers ddMRI imaging protocols, recommended clinical procedures, essential MR facility and patient safety guidelines, hands?on image acquisition, and practical interpretation sessions featuring TMJ and dental cases.
For more details, please visit Introduction to Dental MRI: A Hands?on Program | School of Dentistry.
Learn more at the upcoming American Dental Education Association (ADEA) Annual Session
Visit the Dentsply Sirona booth at the American Dental Education Association (ADEA 2026) Annual Session, taking place March 21–24 in Montréal, Canada, and learn more about the first dental-dedicated magnetic resonance imaging (ddMRI) system.
Learn more at www.dentsplysirona.com/ddmri
Registered brands, trade names and logos are used. Even in particular cases, when they appear without a TM or ®, all corresponding legal rules and provisions apply. All rights are retained by Dentsply Sirona. Clinicians may have been compensated for use of their experiences and testimonials.
About Dentsply Sirona
Dentsply Sirona is the world’s largest diversified manufacturer of professional dental products and technologies, with over a century of innovation and service to the dental industry and patients worldwide. Dentsply Sirona develops, manufactures, and markets a comprehensive solutions offering including dental and oral health products as well as other consumable medical devices under a strong portfolio of world-class brands. Dentsply Sirona’s innovative products provide high-quality, effective and connected solutions to advance patient care and deliver better and safer dental care. Dentsply Sirona is headquartered in Charlotte, North Carolina. The Company’s shares are listed in the United States on Nasdaq under the symbol XRAY. Visit www.dentsplysirona.com for more information about Dentsply Sirona and its products.
Contact Information:
Dentsply Sirona Press Contact:
Marion Par-Weixlberger
Vice President, Public Relations, Corporate Communications & Brand
Publicrelations@dentsplysirona.com | www.dentsplysirona.com
Siemens Healthineers Press Contact:
Stefanie Haug | Magnetic Resonance Imaging, Computed Tomography and X-ray
+49 173 6358240 | stefanie.haug@siemens-healthineers.com
1 The product mentioned here is not commercially available in all countries. Due to regulatory reasons their future availability cannot be guaranteed.
2 Clinical Evaluation Report, MAGNETOM Free.Max Dental Edition, 2025. Copyright@Siemens Healthineers. Data on file.
3 Greiser et al. (2023): Dental-dedicated MRI, a novel approach for dentomaxillofacial diagnostic imaging: technical specifications and feasibility, in: Dentomaxillofacial Radiology, 2023, 00, 1-12
FAQ**
How does the introduction of the MAGNETOM Free.Max Dental Edition by DENTSPLY SIRONA Inc. XRAY influence the current market landscape for dental imaging equipment, particularly in comparison to traditional modalities?
What are the anticipated revenue growth prospects for DENTSPLY SIRONA Inc. XRAY following the FDA clearance and the clinical trial findings regarding the MAGNETOM Free.Max Dental Edition?
How might DENTSPLY SIRONA Inc. XRAY leverage the results of the clinical trial to promote the adoption of the new ddMRI system among dental practices and educational institutions?
What competitive advantages does DENTSPLY SIRONA Inc. XRAY expect to gain from the innovative features of the MAGNETOM Free.Max Dental Edition over existing imaging solutions in dental settings?
**MWN-AI FAQ is based on asking OpenAI questions about DENTSPLY SIRONA Inc. (NASDAQ: XRAY).
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