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
MTU Maintenance Lease Services Invests in TRecs to Digitalise Engine Transition Management13.5.2026 11:05:00 EEST | Press release
MTU Maintenance Lease Services B.V. (“MLS”), the engine leasing and asset management arm of MTU Maintenance, today announced a strategic minority investment in TRecs (trecs.aero). TRecs is a platform digitalising Open Item List (OIL) management across the engine lifecycle, from initial technical review through transitions, shop visits, and beyond. Terms of the transaction are kept confidential. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260513682497/en/ Through its deployment of TRecs, MLS moves further into its leading role in moving the engine leasing industry toward a cloud-based, collaborative standard designed specifically for leasing and asset management customers. MLS will use the platform across the engine lifecycle, from the initial technical review of acquired or leased-in engines through end-of-lease documentation and task tracking for lease returns, shop visits, and asset transitions, in a centralised, real-t
NIPPON KINZOKU Strengthens Promotion of "L-Core" as an Eco-Product: Functional Stainless Steel Achieving High Conductivity via Surface Modification13.5.2026 11:01:00 EEST | Press release
NIPPON KINZOKU CO., LTD. (TOKYO: 5491) (Headquarters: Minato-ku, Tokyo) is proud to announce the strengthened promotion of "L-Core," a functional stainless steel that utilizes proprietary surface modification technology to achieve extremely low contact resistance while maintaining the inherent corrosion resistance of stainless steel. We have repositioned L-Core as a strategic "Eco-Product" to support sustainable manufacturing. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260513728897/en/ While conventional stainless steel excels in corrosion resistance due to its "passive film," this same film typically acts as an electrical insulator. Consequently, components requiring conductivity have traditionally relied on high-cost nickel (Ni) plating or conductive tapes. L-Core solves this challenge by making the passive film itself conductive. This breakthrough ensures high conductivity in the material alone, streamlining the manuf
Hermes Reply Presents Brick Cognitive, the Agentic Operating System for Manufacturing13.5.2026 11:00:00 EEST | Press release
Hermes Reply, the Reply Group company specialized in digital transformation for manufacturing, presents Brick Cognitive, the new agentic operating system designed to bring AI to the centre of industrial operations. A natural extension of Brick Reply, Reply’s next-generation MES/MOM platform, Brick Cognitive introduces a model in which factory systems no longer simply execute and monitor operations, but isable to interpret what is happening, correlate events and guide action across production, quality, maintenance and planning. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260513981153/en/ Brick Reply, Reply’s next-generation MES/MOM platform, Brick Cognitive introduces a model in which factory systems no longer simply execute and monitor operations, but is able to interpret what is happening, correlate events and guide action across production, quality, maintenance and planning. In production environments, data and processe
MC Advances Supply Chain Transformation with Blue Yonder Cognitive Solutions13.5.2026 11:00:00 EEST | Press release
MC, the retail division of Sonae and a leading player in Portugal’s grocery market and health, wellness, and beauty retail across the Iberian Peninsula, has selected Blue Yonder Cognitive Solutions for Allocation and Replenishment to advance its supply chain transformation. With more than 400 stores across multiple formats, MC operates major supermarkets and hypermarkets such as Continente, along with convenience stores, health and wellness shops, and online grocery services. Blue Yonder’s advanced artificial intelligence (AI) and machine learning (ML) enabled solutions will help the company improve visibility into demand forecasting. The new solutions will be implemented by Blue Yonder Services. “The grocery retail sector is adapting to a period of significant change, underlining the need for more agile operations across the supply chain. We needed end-to-end visibility and faster, more accurate inventory planning to address demand uncertainty while prioritizing our business goals,” s
Oral‑B Announces The Big Rethink 2026 , Launching One of Europe’s Largest Disability‑Focused Oral Health Studies13.5.2026 10:06:00 EEST | Press release
Oral‑B today announces The Big Rethink 2026, the next evolution of its flagship oral health inclusion programme, developed in partnership with the International Association for Disability and Oral Health (iADH). The new phase introduces Project Steady, one of Europe’s largest real‑world studies exploring oral care experiences among people with disabilities, their carers and dental professionals. The programme aims to reduce everyday barriers to oral care through inclusive design, evidence-based research and professional education. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260511175864/en/ Oral B Announces The Big Rethink 2026, Launching One of Europe’s Largest Disability Focused Oral Health Studies Oral health for Whole-Body Health Since its launch in 2022, The Big Rethink has been grounded in a clear belief: oral health is fundamental to whole‑body health, confidence and quality of life. For people with disabilities, b
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