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
Doha Debates Examines How Entertainment Shapes Us Today3.12.2025 19:13:00 EET | Press release
Qatar Foundation’s Doha Debates continues its flagship debate series with a new episode that examines how modern entertainment shapes our attention, creativity, and everyday well-being. Moderated by Dareen Abughaida, the debate brings together three influential thinkers to ask whether today’s entertainment landscape is enriching us—or overwhelming us. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251203737439/en/ Doha Debates examines how entertainment shapes us today in a new episode, leading thinkers and students debate whether today’s entertainment elevates us or pulls us into distraction. (Photo: AETOSWire) This week’s debate features Marya Bangee, Senior Advisor at the Pop Culture Collaborative; Dr. Anna Lembke, Professor of Psychiatry at Stanford University and author of Dopamine Nation; and Nicholas Carr, Pulitzer Prize finalist and author of The Shallows. For Bangee, the power of entertainment lies in storytelling t
Vycellix Prepares for First-in-Human Study of Novel Allogeneic Cell Therapy Powered by Its Universal Cell Engineering Platform3.12.2025 19:00:00 EET | Press release
Vycellix, Inc., a biotechnology company developing next-generation allogeneic cell therapies designed to overcome the risk of immune rejection, today announced the successful completion of pre-clinical development for its universal cell engineering platform (VY-UC) with rigorous studies across many donor cell types proving robust immune evasion with functional persistence. The Company is now preparing for first-in-human clinical validation by seeking regulatory approval in Sweden to initiate a Phase 1 study for its lead VY-UC product candidate, a novel, off-the-shelf natural killer (NK) cell therapy (VNK-101) for patients with relapsed or refractory multiple myeloma. VY-UC is a single-step CD45 engager strategy intended to address a central barrier to donor-derived cell therapies, the host immune system’s rapid elimination of allogeneic cells. In pre-clinical studies, VY-UC expression enabled engineered donor cells to evade host cellular immune attack while retaining function, supporti
Pattern Announces Acquisition of ROI Hunter, Connecting Product-Level Advertising and Marketplace Performance for Global Brands3.12.2025 18:01:00 EET | Press release
Pattern Group Inc. (Nasdaq: PTRN), a leader in accelerating brands on global ecommerce marketplaces by leveraging proprietary technology and AI, today announced that it has acquired ROI Hunter a.s., a performance-driven retail media platform for brands and retailers. ROI Hunter integrates product, marketing, and merchandising data into a single source of truth, enabling margin-informed, SKU-level advertising decisions across major walled-garden platforms including Google, Meta, and Snap. The acquisition strengthens Pattern’s position as the world’s leading ecommerce accelerator and expands the company’s AI-driven advertising capabilities across Meta, Google and Snapchat. ROI Hunter brings a defensible, SKU-level data moat anchored in API integrations and more than $1.8B in media managed annually, enabling a uniquely granular view of product-level performance. “We are thrilled to welcome the ROI Hunter team to Pattern,” said Dave Wright, Co-founder and CEO of Pattern. “Their deep techni
DevvStream and Southern Energy Renewables Announce Business Combination Targeting Low-Cost Production of Carbon-Negative SAF and Green Methanol3.12.2025 16:40:00 EET | Press release
DevvStream Corp. (Nasdaq: DEVS) (“DevvStream”), a leading carbon management and environmental-asset monetization firm, and Southern Energy Renewables Inc. (“Southern”), a U.S.-based producer of low-cost fuels made from biomass, with a flagship Louisiana project that plans to utilize regional wood-waste biomass to deliver green methanol and carbon-negative sustainable aviation fuel (“SAF”) at scale, today announced that they have entered into a definitive agreement to combine under a new U.S.-domiciled, Nasdaq-listed company, following customary closing conditions. The new company plans to help aviation and maritime operators meet tightening global mandates from regulations such as ReFuelEU and organizations such as the International Maritime Organization (“IMO”) by creating a U.S.–built, integrated clean‑fuels platform anchored in Louisiana, using domestic feedstock and workforce to produce carbon‑negative SAF and green methanol at commercial scale. Operationally, the combined company
Andersen Consulting Expands Digital Transformation Capabilities3.12.2025 16:30:00 EET | Press release
Andersen Consulting enters into a Collaboration Agreement with Neit Consulting, a firm focused on streamlining operations, integrating smart technologies, and accelerating digital maturity for clients. Neit Consulting is a business consulting firm based in the Czech Republic with more than 20 years of experience delivering ISO-certified IT and business advisory services across data analytics, performance management, and process optimization. With more than 200 consultants, the firm supports clients—including global banks, insurers, manufacturing companies, and public entities—through business consulting, IT systems implementation, and long-term systems support. Neit Consulting serves clients globally with a focus on aligning digital capabilities to complex operational needs. “This collaboration represents a significant step forward in the scope of services provided to our clients,” said Tomáš Niederle, sales director of Neit Consulting. “Andersen’s global reach and multidisciplinary ap
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