DentalMonitoring Sets New Standard in Orthodontic Remote Monitoring With EU-MDR Certification
14.6.2024 20:33:00 EEST | Business Wire | Press release
DentalMonitoring is proud to announce that the DentalMonitoring Software is now certified under the European Union Medical Device Regulation 2017/745 (EU MDR) and fulfills the requirements for CE marking as a class IIa medical device. European Medical Device Regulation 2017/745 (EU MDR) replaces the previous Medical Device Directive 93/42/EEC (MDD). EU MDR sets more rigorous requirements for clinical evaluation, risk management, post-market surveillance, and data collection on medical devices.(1) This landmark achievement underscores DentalMonitoring's commitment to advancing dental care through cutting-edge technology and rigorous regulatory compliance. Achieving this certification four years ahead of the deadline demonstrates DentalMonitoring's commitment to positioning itself as an innovative, serious, efficient, and safe player in the medical field.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240614842101/en/
DentalMonitoring Sets New Standard in Orthodontic Remote Monitoring with EU-MDR Certification (Graphic: Business Wire)
DentalMonitoring is a medical device software using image processing algorithms to analyze high-quality intraoral scans taken by patients using the DM App, a smartphone, and proprietary hardware. The software allows healthcare professionals to remotely monitor dental treatments, orthodontic treatments, oral health, and treatment progress. The medical device software aids clinicians in diagnosis and treatment planning through weekly clinical updates.
With DentalMonitoring, clinicians enjoy an elevated level of insight into treatment progress while patients enjoy increased convenience. Automated notifications and in-app communication with practice staff increase patient accountability and enhance communication between patients and healthcare providers. This level of connection promotes patient compliance with orthodontic treatment requirements.
Philippe Salah, CEO and co-founder of DentalMonitoring, said, “I’m incredibly proud that DentalMonitoring has achieved EU MDR certification along with US/FDA DeNovo 510k clearance. These achievements celebrate our relentless pursuit of innovation and excellence in oral care. Our AI-powered solutions are now recognized at the highest regulatory levels, enabling us to expand our reach and impact more lives with advanced dental technology.”
“The requirements of EU MDR are much more rigorous, sometimes compelling medical device manufacturers to rethink their European commercial strategy. We are very pleased to have successfully met these requirements four years before the deadline set by the European Union. EU MDR Certification is a significant milestone that underscores DentalMonitoring's commitment to quality, efficiency and patient safety,” said Arnaud Berthier, Director of Regulatory, Quality and Clinical Affairs at DentalMonitoring.
About DentalMonitoring:
DentalMonitoring is transforming orthodontic care globally through our advanced AI-driven platform. Our mission is to empower orthodontic practitioners with precise, real-time treatment monitoring and decision-making tools. By enhancing the connection between clinicians and patients, we make it possible to optimize treatment outcomes and ensure high-quality, efficient, and personalized orthodontic experiences. Visit www.DentalMonitoring.com and follow DentalMonitoring on LinkedIn.
(1) |
View source version on businesswire.com: https://www.businesswire.com/news/home/20240614842101/en/
Contacts
Celine Cendras-White
Head of Marketing Communication
public-relations@dental-monitoring.com
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Fortegra Completes Acquisition by DB Insurance29.5.2026 23:30:00 EEST | Press release
The Fortegra Group, Inc. ("Fortegra"), a global specialty insurance company, today announced the completion of its acquisition by DB Insurance Co., Ltd. ("DB"), one of Korea's leading property and casualty insurers. The transaction, announced on September 26, 2025, received all required regulatory and stockholder approvals. Fortegra will operate independently, maintaining its existing leadership team, distribution relationships, and underwriting discipline. Agents, distribution partners, and customers will continue to experience the service excellence that has defined the Fortegra experience. Richard Kahlbaugh, Chairman and CEO of Fortegra, said: "Every company eventually changes ownership. That is the nature of business. The closing of this acquisition is a starting point. As part of DB Insurance, Fortegra is positioned to expand our business geographically, enhance our capabilities and deepen our market presence in the US, Europe, the United Kingdom and Asia. Together, DB Insurance a
SINOVAC Receives Nasdaq Notification Regarding Late Filing of 2025 Annual Report29.5.2026 23:01:00 EEST | Press release
Sinovac Biotech Ltd. (Nasdaq: SVA) (“SINOVAC” or the “Company”), a leading provider of biopharmaceutical products in China, today announced that it received a notification letter dated May 20, 2026 (the “Notification Letter”), from Nasdaq Listing Qualifications (“Nasdaq”) stating that as of May 8, 2026, the Company had regained compliance with the periodic filing and interim financial requirements in Nasdaq Listing Rules 5250(c)(1) (the “Periodic Filing Rule”) and 5250(c)(2), as required by the Panel’s decision dated January 21, 2026. As previously disclosed on January 22, 2026, under the Panel’s decision, SINOVAC was required to, on or before May 11, 2026, demonstrate compliance with such Nasdaq Listing Rules by completing filings of its annual report for the year ended December 31, 2024, on Form 20-F and an interim balance sheet and income statement as of the end of its second quarter of 2025 on Form 6-K. The Company timely completed such filings as required by the Panel’s decision.
From Network Automation to Agentic NetOps: NetBrain Sets the Standard for Deploying AI in Network Operations29.5.2026 16:00:00 EEST | Press release
NetBrain Technologies, Inc. today announced major new platform features that advance Agentic NetOps from an emerging category to operational reality. NetBrain's clients are already deploying agents that are diagnosing and remediating issues across complex multi-vendor enterprise networks. These new features further extend the platform with new agent tooling, cross-domain context, and open interfaces for the broader agentic enterprise. Early customer outcomes show the magnitude of the shift: A leading health insurer used NetBrain's Deep Diagnosis agent to diagnose and resolve a weeks old VPN connectivity issue in under five minutes. A large manufacturer resolved a critical device issue with a single prompt, isolating the root cause across the network path in under 20 minutes, saving hundreds of hours of engineer time, shrinking MTTR by more than 95%. A global telecommunications firm found NetBrain's context-grounded agents outperformed a stand-alone frontier LLM on a persistent firewall
Adtran resolves long-running patent litigation, reinforcing commitment to defend innovation29.5.2026 15:00:00 EEST | Press release
Adtran today announced it has resolved a patent litigation matter, resulting in a full settlement and dismissal of all claims with prejudice. The case, initiated in 2020 by a non-practicing entity asserting five patents, was transferred to the US District Court for the Northern District of Alabama in 2021 following a successful motion by Adtran. Adtran subsequently filed counterclaims, including bad-faith patent assertion under Alabama statutory law. The settlement includes payment to Adtran to resolve its counterclaims. Terms of the agreement remain confidential. “This outcome reflects a disciplined and consistent approach to protecting our innovation and our customers,” said Justin Ferguson, SVP and general counsel at Adtran. “We take all claims seriously, but we will not hesitate to defend ourselves when assertions lack merit. Situations like this place unnecessary strain on technology providers and divert resources from advancing networks and services. By advancing our counterclaim
Meiji Seika Pharma Invests in GHIC’s Global Health Security Fund29.5.2026 14:00:00 EEST | Press release
Meiji Seika Pharma Co., Ltd. (Headquarters: Tokyo, Japan; President and Representative Director: Toshiaki Nagasato) today announced that it has committed to invest in the Global Health Security Fund (GHSF), which is sponsored by Global Health Investment Corporation (GHIC), a New York-based nonprofit organization. Through this investment, Meiji Seika Pharma will support the acceleration of innovations addressing critical global health challenges, including pandemic preparedness and antimicrobial resistance (AMR). GHIC is a mission‑driven nonprofit organization that deploys private investment strategies to generate both global health impact and financial returns. GHIC recently closed its second fund in GHSF. With more than a decade of experience investing in the field of infectious disease, GHIC has contributed to addressing major global health challenges. Its portfolio companies have successfully commercialized more than a dozen products, collectively reaching over 600 million people wo
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom