DentalMonitoring Sets New Standard in Orthodontic Remote Monitoring With EU-MDR Certification
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
Hemato-Oncology Trials: AOP Health Presents New Results at Top Congress ASH7.12.2025 18:00:00 EET | Press release
AOP Health continues to advance its clinical research program in myeloproliferative neoplasms, a special group of rare blood cancers. The company, specialized in rare diseases, presented the results of two scientific investigations at the 67th American Society of Hematology Association (ASH) Annual Meeting 2025 held in Orlando, FL, USA. The results provide new insights in treatment strategies. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251207587915/en/ Dr. Martin Steinhart, CEO AOP Health; Photo credit: AOP Health/Studio Koekart ROP-ET and BESREMI PASS One of the clinical studies, ROP-ET, examined the use of ropeginterferon alfa-2b in people with essential thrombocythemia (ET), a disease in which the body produces too many platelets. The trial, a prospective, multicenter, single-arm phase III study, investigated the safety and efficacy of ropeginterferon alfa-2b in ET patients unable to receive available cytoreductive th
CoMotion GLOBAL 2025 Launches in Riyadh: Global Mobility Leaders Unite in Saudi Capital to Chart Urban Future7.12.2025 14:00:00 EET | Press release
Riyadh is rapidly becoming one of the world's most ambitious urban mobility laboratories, where next-generation technologies move from blueprint to real-world deployment on city streets at unprecedented scale. CoMotion GLOBAL 2025, the world's most influential gathering of urban mobility leaders, opens today in Riyadh for a three-day summit bringing together innovators from Africa, Asia, Europe, the Americas, and the Middle East. Running December 7-9, the event will explore how electrification, autonomy, AI-enabled transport, and giga-project urbanism are reshaping cities worldwide. The summit will spotlight everything from high-performance EVs and breakthrough autonomous fleets to emerging-market transport solutions and new mobility models, demonstrating how the Kingdom is opening new pathways for global mobility leadership. Strategic Partnerships Powering the Summit CoMotion GLOBAL 2025 is hosted by the Saudi Conventions & Exhibitions General Authority (SCEGA), supported by key Saudi
Deciphera Announces Oral Presentation of Positive Topline Results from Phase 2a Study of Sapablursen in Polycythemia Vera at the 67 th American Society of Hematology (ASH) Annual Meeting6.12.2025 16:30:00 EET | Press release
Deciphera Pharmaceuticals, a member of Ono Pharmaceutical Co., Ltd. (Headquarters: Osaka, Japan; President and COO: Toichi Takino; “Ono”), today announced the oral presentation of positive results from the Phase 2a IMPRSSION study of sapablursen in patients with polycythemia vera (PV) at the 67th American Society of Hematology (ASH) Annual Meeting, taking place December 6-9, 2025, in Orlando, FL. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251206361611/en/ The results were presented by Ionis Pharmaceuticals, who discovered and developed sapablursen and conducted the IMPRSSION study. In March 2025, Ionis and Ono entered into a license agreement in which Ono obtained exclusive global rights for the development and commercialization of sapablursen. “In the treatment of PV, phlebotomy and cytoreductive therapy are performed as treatments for preventing thrombosis. Phlebotomy is the most common treatment for PV, in which blood
Protagonist and Takeda Present Longer-Term Data at ASH 2025 Showing Rusfertide Delivers Durable Response and Hematocrit Control in Polycythemia Vera6.12.2025 16:30:00 EET | Press release
Protagonist Therapeutics, Inc. (“Protagonist”) (NASDAQ:PTGX) and Takeda (TSE:4502/NYSE:TAK) announce that new 52-week results from the pivotal Phase 3 VERIFY study evaluating rusfertide in patients with polycythemia vera (PV) will be presented in an oral presentation at the 67th American Society of Hematology (ASH) Annual Meeting and Exposition. These findings further reinforce rusfertide’s efficacy and safety and demonstrate durability of response, with 61.9% of patients continuously treated with rusfertide maintaining absence of phlebotomy eligibility from baseline to Week 52. “The 52-week data demonstrated the sustained efficacy of rusfertide, reducing the need for patients to receive phlebotomy while maintaining hematocrit control,” said Dr. Andrew T. Kuykendall, M.D., VERIFY Lead Investigator and Associate Member in the Department of Hematology at Moffitt Cancer Center. “The 32-week VERIFY primary results were already promising, and this deeper understanding of the durability of r
Vertex Presents New Data on CASGEVY ® , Including First-Ever Data in Children Ages 5-11 Years, at the American Society of Hematology Annual Meeting and Announces Plan for Global Regulatory Submissions6.12.2025 14:01:00 EET | Press release
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced data from multiple studies demonstrating the clinical benefits of CASGEVY® (exagamglogene autotemcel) in people ages 5 years and older living with severe sickle cell disease (SCD) or transfusion-dependent beta thalassemia (TDT). The results, including the first presentation of clinical data from pivotal studies in children ages 5-11 years, and longer-term data from the pivotal studies of people with severe SCD and TDT ages 12 years and older, will be presented at the American Society of Hematology (ASH) Annual Meeting. CASGEVY is currently approved for eligible people ages 12 years and older with SCD or TDT in the United States, Great Britain, the European Union, the Kingdom of Saudi Arabia, the Kingdom of Bahrain, Kuwait, Qatar, Canada, Switzerland and the United Arab Emirates. “These results — the first clinical data ever presented on any genetic therapy for children ages 5-11 years with SCD — again demonstrate the tr
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