DENTALMONITORING
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) |
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240614842101/en/
About Business Wire
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
Verimatrix: Signing of an Agreement for the Sale of XTD Assets (Code and Application Protection) to Guardsquare8.12.2025 17:45:00 CET | Press release
Sale of XTD assets (mobile application protection) including a portfolio of patents and a team of experts for an initial offer of $8.5m, the final price will be adjusted at the closing.Verimatrix refocuses on Anti-Piracy (video protection), the group's core business representing approximately 90% of its total revenue Regulatory News: VERIMATRIX (Euronext Paris: VMX, FR0010291245), a leading provider of user security solutions for a safer connected world, announces the signing of an agreement with Belgium-based Guardsquare, the leading provider of mobile application security, for the sale of its Extended Threat Defense (XTD) assets. Guardsquare, the creators of the open-source optimization tool, ProGuard, offers the most complete mobile application security platform on the market spanning automated testing and multi-layered protection, real time threat monitoring, and app attestation. Guardsquare’s 975+ customers are located in more than 95 countries and represent all major industries.
WNBA Champion Sabrina Ionescu Becomes Global Brand Ambassador for Ant International8.12.2025 17:00:00 CET | Press release
Four-time WNBA All-Star Sabrina Ionescu today becomes a new Global Brand Ambassador for Ant International, a leading global provider of digital payments, digitisation, and financial technology. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251208536426/en/ The partnership is built on a shared commitment to creating a more inclusive and sustainable world through empowering underserved communities and youth groups with sports and technology innovation. It marks an important step in Ant International’s journey to foster growth and expand access to financial tools through innovative technology. Ionescu serves as the first Ant International global brand ambassador from North America. “Sabrina embodies the spirit of perseverance and the passion for excellence that is driving young talents and small businesses around the world to uplift their communities,” said Douglas Feagin, President of Ant International. “As a legend in a spor
SABCS 2025: REVEAL GENOMICS Presents Major Advance in Predicting Brain Metastasis in HER2+ Breast Cancer8.12.2025 16:20:00 CET | Press release
The new HER2DX central nervous system (CNS) progression score predicts risk of brain progression in advanced HER2+ breast cancer, addressing a major unmet need in identifying patients at the highest risk of CNS involvement. During SABCS 2025, the company presents a total of 7 studies with 1,300 tumor samples analyzed, covering HER2-positive, ER-negative, and triple-negative breast cancer (TNBC), representing one of the largest and most comprehensive genomic data contributions to the symposium. New clinical evidence includes superior pCR prediction compared with TILs, demonstration of real-time genomic testing feasibility in an international trial, and validation of RNA-based ERBB2 assessment to accelerate clinical decision-making. REVEAL GENOMICS, S.L., a Barcelona-based biotechnology company focused on advancing precision oncology through biomarker innovation, announced today the presentation of seven studies at the upcoming San Antonio Breast Cancer Symposium (SABCS) 2025, held Decem
NetApp Advances EMEA & LATAM Presence with Appointment of Willem Hendrickx as Customer Demand for AI Accelerates8.12.2025 16:15:00 CET | Press release
A leader in driving enterprise transformation, Hendrickx brings nearly three decades of experience, strengthening global partner ecosystems and customer relationships across regions NetApp (NASDAQ: NTAP), the intelligent data infrastructure company, today announced the appointment of Willem Hendrickxas Senior Vice President and General Manager, EMEA & LATAM, effective January 5, 2026. Hendrickxwill lead NetApp’s business strategy, go-to-market execution, and partner engagement across Europe, the Middle East, Africa, and Latin America. Reporting to NetApp President César Cernuda, Hendrickx brings a deep regional knowledge and track record of building high-performing teams, further enabling the acceleration of NetApp’s international footprint by helping global customers navigate the evolving demands of hybrid cloud and AI-driven data infrastructure. Hendrickx holds a Master’s degree in Applied Economics from KU Leuven and is based in Brussels, Belgium. “Willem joins NetApp at a pivotal t
MediaKind and Harmonic’s Video Business to Combine, Creating a Leading Streaming-Infrastructure Platform8.12.2025 15:37:00 CET | Press release
Combined business will be the #1 independent comprehensive streaming-infrastructure platformBrings together complementary product teams to drive faster advancement across cloud and appliance technologiesFurthers MediaKind’s mission to redefine the future of media and entertainment through advanced video technology MediaKind, a global leader in cloud-based video streaming technology, today announced it has entered into an agreement to acquire the Video Business of Harmonic Inc. (NASDAQ: HLIT) for approximately $145 million. Following a French employee works council consultation process, the parties would immediately execute a purchase agreement, and the transaction would be expected to close in the first half of 2026, subject to customary regulatory approvals and closing conditions. The transaction creates a world-class independent SaaS streaming infrastructure provider by combining two established video technology organizations with complementary strengths in SaaS streaming, appliance
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