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
Fi Expands International Footprint to 38 Countries Worldwide2.6.2026 20:25:00 EEST | Press release
Fi, the leader in smart pet technology, today announced a major international expansion, bringing its AI-powered GPS pet wearables and connectivity network to 38 countries across North America and Europe. Fi devices are now available for purchase in 29 markets, including newly added countries such as Finland, Sweden, Denmark, Austria, Belgium, the Netherlands, Romania, Slovakia, and Latvia. Through Fi's international connectivity network, customers can also use Fi in Switzerland, Norway, Liechtenstein, Iceland, and Turkey, bringing Fi's total coverage footprint to 38 countries. The expansion reflects growing demand from pet owners who want reliable connectivity and health insights, whether they're at home or traveling abroad. "Wherever your pet roams, Fi should work," said Jonathan Bensamoun, Founder and CEO of Fi. "As more pet owners travel internationally and expect seamless connectivity, we're expanding Fi's footprint to help them stay connected to their pets across more of Europe a
XFolio AI Acquires Absolute Payment Solutions to Unify Treasury and Payments for UK Corporates2.6.2026 20:16:00 EEST | Press release
XFolio AI (xfolio.ai), a Paris-based treasury and cash management technology group, has acquired Absolute Payment Solutions (APS) (https://www.absolutepayments.com/), one of a select number of Pay.UK-accredited Bacs service providers in the UK. This acquisition creates an integrated platform spanning Bacs and all payment types, open banking, risk management, and treasury—giving UK corporates of all sizes the tools to manage cash and execute payments in one place. APS’s Bacs accreditation underpins payment services relied upon daily by organisations across both the public and private sectors, from SMEs running payroll and direct debit collections to large corporates processing high-volume payment flows. While enterprise payment platforms often demand significant scale and budget, and lighter solutions trade capability for speed of setup, APS and XFolio together deliver accredited Bacs infrastructure combined with advanced treasury intelligence across SWIFT, API, H2H, and EBICS rails—wit
Amazfit Introduces a New Era of Hybrid Training with Balance 3 and Balance Ultra2.6.2026 20:00:00 EEST | Press release
Amazfit, a leading global smart wearable brand owned by Zepp Health, today unveiled the Amazfit Balance 3 and Amazfit Balance Ultra, the newest additions to the Balance series and the hero watches for Amazfit’s new Hybrid Training System, connecting performance tracking with intelligent training guidance through the Zepp App. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260602329170/en/ Built around how modern athletes train today, Balance 3 and Balance Ultra are designed for people balancing strength, endurance, recovery, work, stress, and daily life. The devices serve as the engine layer of the connected Hybrid Training ecosystem, capturing how users train, recover, and respond over time. The products were unveiled at a launch event in New York during a panel hosted by leading voices from the fitness and HYROX community. Built around how modern athletes train today, Balance 3 and Balance Ultra are designed for people bal
Mouser's Rise of the Robots Program Explores Humanoid Design Considerations2.6.2026 18:19:00 EEST | Press release
Mouser Electronics, Inc., the authorized global distributor with the newest electronic components and industrial automation products, today announced the latest installment of its Empowering Innovation Together (EIT) technology series, Rise of the Robots, which explores key technologies behind humanoid robots and their potential for transformation. The series shares how these robots have progressed from simple machinery to critical tools used in caregiving, industrial automation, education, and even in the harshest environments. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260602293561/en/ The latest EIT installment explores the engineering design process, system integration challenges, and the role of legacy infrastructure, safety, and ROI in shaping scalable humanoid robot deployment. While science fiction has long envisioned robots resembling humans, recent advances in sensing, actuation, AI, embedded computing, and pow
Blue Cloud Ventures Announces Final Close of Blue Cloud Ventures V2.6.2026 17:35:00 EEST | Press release
Blue Cloud Ventures (BCV), a venture growth firm focused on investing in enterprise software companies, announced the final close of its fifth fund, Blue Cloud Ventures V (BCV V). This milestone reinforces the firm’s continued mission to back category-defining companies that are poised to thrive in the age of AI. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260602186634/en/ At the core of BCV’s strategy is building deep conviction in and backing companies that possess the potential to define or reshape entire industries. With BCV V, the firm is doubling down on its AI-first investment thesis, aiming to back and support visionary teams on their long-term growth journey as they build the systems that will serve as the backbone of the modern enterprise. Blue Cloud typically invests between $10 and $30 million as a lead, co-lead, or co-investor. Beyond support with strategy, recruiting, and customer introductions, the firm pro
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