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
Arthur D. Little and Vega IT Unveil Joint Venture for Digital Innovation5.12.2025 16:00:00 CET | Press release
Arthur D. Little (ADL) and Vega IT today announced the formation of Axceler8 Solutions, a 50/50 joint venture created to design, develop, and operate a portfolio of digital and AI solutions aimed at improving efficiency and automating complex business processes. The launch of this new company is the direct outcome of a year of successful collaboration between the two firms and marks a new phase in their shared ambition to bring scalable, high-performance digital solutions to market, aiming to further augment their clients’ capacity to compress time to impact in a variety of domains. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251205465303/en/ Arthur D. Little and Vega IT have announced the formation of Axceler8 Solutions, a 50/50 joint venture created to design, develop, and operate a portfolio of digital and AI solutions. Axceler8 Solutions’ first product, Axceler8 Rx, is now live as a newly developed platform, and is a
Lone Star Announces Sale of SPX FLOW to ITT Inc.5.12.2025 13:30:00 CET | Press release
Lone Star Funds (“Lone Star”) today announced the signing by an affiliate of Lone Star Fund XI, LP of a definitive agreement to sell SPX FLOW, Inc. (“SPX FLOW”), a leading provider of highly engineered equipment and process technologies for attractive end markets including industrial, health and nutrition, to ITT Inc. (NYSE: ITT) for $4.775 billion in cash and shares of common stock. Based in Charlotte, N.C., SPX FLOW focuses on process technologies delivering mixing, blending, fluid handling, separation, thermal heat transfer and other solutions integral to industrial, health and nutrition markets. The company has operations in more than 25 countries and sales in more than 140 countries. In partnership with Lone Star, SPX FLOW has focused on improving its sales execution and operating platform, while ensuring high quality and innovative product development. The management team has improved the company’s commercial organization and executed growth initiatives to build its presence in e
AmTrust Financial Services and Blackstone Credit & Insurance Close Strategic Transaction and Launch Newly Formed Multinational MGACompany Named ANV Group Holdings Ltd.5.12.2025 13:00:00 CET | Press release
Strategic Transaction Unlocks Value for AmTrust and Positions ANV Group Holdings for Accelerated GrowthFormer AmTrust President Adam Karkowsky Leading ANV Group Holdings as Chairman and CEO AmTrust Financial Services, Inc. (“AmTrust” or the “Company”), a global specialty property casualty insurer, and Blackstone Credit & Insurance (“BXCI”), today announced the closing of a strategic transaction under which AmTrust and funds managed by BXCI have partnered to spin-off certain of AmTrust’s Managing General Agencies (“MGAs”) and fee-based businesses in the U.S., United Kingdom, and Continental Europe, into ANV Group Holdings Ltd. (“ANV”), a newly formed independent company, following receipt of regulatory approvals. AmTrust and ANV have entered into a ten-year capacity agreement through which AmTrust will remain the underwriter for the existing books of business offered through the MGAs. As previously announced on September 15, 2025, the agreement includes seven AmTrust subsidiaries: ANV S
Galderma Opens up New Chapter for Sculptra® with MDR Certification and New Expanded Indication for Body5.12.2025 07:00:00 CET | Press release
Sculptra®, the first proven regenerative biostimulator, has received European Union (EU) Medical Device Regulation (MDR) certification, expanding its current clinical application for the face to include gluteal area, posterior thighs, décolletage, and upper arms1 Studies investigating the efficacy of Sculptra on areas beyond the face show patients experienced progressive improvements in skin quality (including the improvement in cellulite appearance), firmness, lift, projection, and contour Sculptra’s versatility and new indication allow practitioners to shift patient treatment goals beyond rejuvenation toward enhancement, meeting evolving patient needs The certification validates Sculptra’s safety performance, efficacy, and quality, reinforcing Galderma’s commitment to innovation and meeting evolving patient needs Galderma (SIX: GALD), the pure-play dermatology category leader, today announced the certification of Sculptra for body indications in the European Union (EU) following its
Northern Escape Heli-Skiing Takes the Title of “World’s Best Heli-Ski-Operator” for the 4th Year Running5.12.2025 02:40:00 CET | Press release
4x World’s Best Heli-Skiing Operation near Terrace, BC Northern Escape Heli-Skiing (NEH) has been named World’s Best Heli-Ski Operator 2025 by the World Ski Awards, marking its fourth straight victory following years 2022, 2023 and 2024. This recognition places NEH amongst an elite group of ski tourism operators consistently voted best in the world by industry leaders and enthusiasts alike. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251204074550/en/ A four-year run built on reliability NEH operates in British Columbia’s Skeena Mountains, where deep northern snow and vast terrain come together with small-group heli-skiing and heli snowboarding. When helicopters can’t safely fly, NEH has cat skiing readily available as a backup — an exceedingly rare offering in this industry. The operation spans over 833,571 wild acres of alpine bowls, glaciers and old-growth tree skiing. The NEH experience Guests choose from three lodge f
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