First-ever Dental Dedicated MRI Validated in Clinical Trial and Cleared by FDA for Advanced Soft-Tissue Diagnostics

Rhea-AI Summary

Dentsply Sirona and Siemens Healthineers (NYSE: XRAY) announced FDA clearance of the MAGNETOM Free.Max Dental Edition, the first dental-dedicated MRI, following a clinical trial validating its use across endodontics, periodontics, TMJ, extraction, and orthodontics.

The trial highlighted non-ionizing imaging, dental-specific field of view, under 20-minute average workflow, soft-tissue contrast that differentiates active inflammation and assesses tooth pulp vitality, and positioning relative to nerves. Training and demonstrations planned April 2026 and at ADEA March 21–24, 2026 in Montréal.

Positive

• FDA clearance granted for the MAGNETOM Free.Max Dental Edition
• Clinical trial validated multi‑specialty dental applications
• Average patient workflow time maintained under 20 minutes
• Non‑ionizing imaging enabling advanced soft tissue contrast

Negative

• Primarily intended for hospitals, large clinics, and universities
• May require specialized training and MR facility readiness

News Market Reaction – XRAY

+0.47%

1 alert

+0.47% News Effect

On the day this news was published, XRAY gained 0.47%, reflecting a mild positive market reaction.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Average workflow time: under 20 minutes Training course duration: two-day course ADEA 2026 dates: March 21–24, 2026

3 metrics

Average workflow time under 20 minutes Clinical trial workflow for ddMRI system

Training course duration two-day course Advanced hands-on ddMRI training in April 2026

ADEA 2026 dates March 21–24, 2026 American Dental Education Association Annual Session

Market Reality Check

Price: $12.73 Vol: Volume 5,043,261 is below...

normal vol

$12.73 Last Close

Volume Volume 5,043,261 is below 20-day average 6,034,083 (relative volume 0.84). normal

Technical Shares at $12.74 are below the 200-day MA of $13.43 and 25.84% under the 52-week high.

Peers on Argus

XRAY fell 4.43% with several peers also lower (NVST -1.94%, WRBY -5.12%, ICUI -1...

1 Up

XRAY fell 4.43% with several peers also lower (NVST -1.94%, WRBY -5.12%, ICUI -1.37%, MMSI -0.21%), while LMAT rose 2.22%, indicating mixed but generally soft sentiment in related names.

Historical Context

5 past events · Latest: Mar 03 (Neutral)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Mar 03	Conference participation	Neutral	+1.1%	Announcement of presentation at the Leerink Partners Global Healthcare Conference.
Feb 26	Earnings and outlook	Positive	+15.5%	Q4 and FY 2025 results with 2026 guidance and restructuring details.
Feb 24	Board appointments	Positive	-2.6%	Addition of experienced directors supporting Return-to-Growth plan.
Feb 24	Distribution partnership	Positive	+4.7%	Expanded Burkhart partnership to include full dental technology portfolio.
Feb 05	Earnings call notice	Neutral	+9.8%	Scheduling of Q4 and FY 2025 results call and webcast.

Pattern Detected

Recent news often saw positive price reactions, including a strong move on earnings and constructive responses to partnerships and conference-related updates, with only one governance-related announcement drawing a negative move.

Recent Company History

Over the last few weeks, XRAY has issued multiple updates. An earnings release on Feb 26, 2026 with 2025 results and 2026 outlook saw shares rise 15.5%. A distribution partnership expansion on Feb 24, 2026 lifted the stock 4.7%, while new board appointments the same day coincided with a -2.59% move. Conference-related announcements on Feb 5 and Mar 3, 2026 produced gains of 9.82% and 1.05%. Today’s FDA-cleared dental-dedicated MRI clinical trial news adds to this sequence of strategic and clinical milestones.

Market Pulse Summary

This announcement highlights FDA clearance and clinical validation of a first-of-its-kind dental-ded...

Analysis

This announcement highlights FDA clearance and clinical validation of a first-of-its-kind dental-dedicated MRI system with workflow under 20 minutes and advanced soft-tissue visualization. It extends Dentsply Sirona’s imaging portfolio and targets hospitals, large clinics, and universities. In the past months, earnings, partnerships, and governance updates have driven notable moves, suggesting the market closely tracks execution. Key watchpoints include adoption of ddMRI, ongoing clinical education efforts, and follow-up data on utilization.

Key Terms

mri, tmj, ionizing radiation, cbct, +2 more

6 terms

mri medical

"first-ever dental-dedicated MRI1 (ddMRI) system – MAGNETOM Free.Max Dental Edition"

Magnetic resonance imaging (MRI) is a medical scan that uses magnetic fields and radio waves to create detailed pictures of the inside of the body, like a high-resolution camera for tissues and organs. Investors care because MRI drives demand for imaging machines, hospital services, diagnostics and can be central to clinical trial results and regulatory decisions—changes in MRI use or technology can affect revenue, capital spending and reimbursement in healthcare and medical device markets.

tmj medical

"applicability in endodontics, periodontics, TMJ, tooth extraction, and orthodontics"

TMJ stands for the temporomandibular joint, the small hinge on each side of the jaw that lets the mouth open, close and move side to side; problems there are often called TMJ disorders. Investors care because treatments, devices or drugs for TMJ issues involve healthcare markets, regulatory approvals, insurance coverage and potential liability, so progress or setbacks can affect revenue prospects for companies making dental, medical device or therapeutic products—think of it as demand for parts and repairs when a commonly used hinge wears out.

ionizing radiation medical

"without the risks associated with ionizing radiation"

High-energy particles or waves (such as X-rays, gamma rays, or certain fast-moving particles) that can remove electrons from atoms and change chemical structures; imagine tiny, invisible billiard balls or flashes that can knock pieces out of place at the atomic level. Investors care because exposure or use of ionizing radiation drives strict safety rules, permits, cleanup costs, product approvals and liability risks for companies in healthcare, energy, manufacturing and environmental services.

cbct medical

"ddMRI complements intraoral, panoramic, and CBCT imaging"

Cone beam computed tomography (CBCT) is a type of 3D X‑ray scan that creates detailed, three‑dimensional images of teeth, jaws and facial bones by rotating a cone‑shaped X‑ray beam around the head. For investors, CBCT matters because it drives demand for specialized imaging equipment, software and clinics; changes in adoption, reimbursement or regulatory approval can directly affect revenues and margins in dental and medical device businesses. Think of it as upgrading from a flat photo to a full 3D model that clinicians use to plan treatment more precisely.

magnetic resonance imaging medical

"first dental-dedicated magnetic resonance imaging (ddMRI) system"

Magnetic resonance imaging (MRI) is a medical scan that uses strong magnets and radio waves to make detailed pictures of the inside of the body without X-rays or surgery. For investors, MRI matters because the machines, software, maintenance, and scan services represent steady capital spending and revenue streams for equipment makers, hospitals and imaging centers; advances or wider adoption can change market size, pricing power and competitive dynamics much like a camera upgrade transforms picture quality and demand.

dentomaxillofacial medical

"Specifically designed to enhance dentomaxillofacial diagnostics"

A dentomaxillofacial area or procedure involves the teeth, jaws and surrounding facial structures—think of the combined work of dentists and facial surgeons focused on oral and jaw health. Investors care because treatments and devices in this specialty (like implants, corrective surgery tools and imaging systems) represent a distinct medical market with regulatory approvals, reimbursement rules and long-term patient demand that can affect revenue and growth for healthcare companies.

AI-generated analysis. Not financial advice.

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

What did Dentsply Sirona and Siemens announce about the MAGNETOM Free.Max Dental Edition (XRAY) on March 9, 2026?

They announced FDA clearance for the MAGNETOM Free.Max Dental Edition as the first dental-dedicated MRI. According to Dentsply Sirona and Siemens Healthineers, a clinical trial validated its use across multiple dental specialties and advanced soft-tissue diagnostics without ionizing radiation.

How does the ddMRI (MAGNETOM Free.Max) improve dental diagnosis for XRAY shareholders and clinicians?

The ddMRI provides enhanced soft-tissue contrast and can differentiate active inflammation from scar or healthy tissue. According to Dentsply Sirona, it also enables non-invasive tooth pulp vitality assessment and visualization of teeth relative to nerves, complementing CBCT and intraoral imaging.

What are the workflow and practical use details for MAGNETOM Free.Max Dental Edition (XRAY)?

The system maintains an average workflow time under 20 minutes for patient preparation and scanning. According to Siemens Healthineers, the dental-specific coil and software focus imaging on dental structures, avoiding brain tissue and streamlining clinical use.

Who is the primary target user for the dental-dedicated MRI (XRAY) and where will it be used?

The device is primarily intended for hospitals, large clinics, and universities rather than general dental offices. According to the companies, ddMRI is aimed at institutions equipped for MR imaging and advanced dentomaxillofacial diagnostics.

When and where can clinicians access training or see MAGNETOM Free.Max Dental Edition (XRAY) demonstrations?

An advanced hands-on training course is scheduled for April 2026 at the University of Minnesota, and demonstrations will occur at ADEA March 21–24, 2026 in Montréal. According to Dentsply Sirona, sessions cover imaging protocols, safety, and interpretation.