DENTALMONITORING
14.6.2024 19:35:30 CEST | 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) |
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
Alnylam Presents New Data at ESC Congress 2026 Reinforcing Strength in RNAi-Powered TTR Silencing Across ATTR-CM Patient Populations and Treatment Settings30.8.2026 14:23:00 CEST | Press release
–Late-Breaking Prespecified Subgroup Analysis of HELIOS-B Demonstrates that Vutrisiran Provided Consistent Clinical Benefit Across All-Cause Mortality and Recurrent Cardiovascular Events in Patients With or Without Tafamidis Use at Baseline ––Additional Post Hoc Analyses Highlight Positive Impact of Vutrisiran in Addressing the Multisystemic Manifestations of ATTR-CM ––Pooled Analysis Across Four Positive Phase 3 Studies of Vutrisiran and Patisiran Shows Consistent Treatment Effect Across Sexes ––New Subgroup Analysis from KARDIA-3 Phase 2 Study of Zilebesiran Highlights Potential to Provide Enhanced Blood Pressure Control – Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today announced new data at the European Society of Cardiology (ESC) Congress 2026 demonstrating the strength of RNAi-powered silencing for cardiovascular disease. The findings further reinforce the clinical profile of AMVUTTRA® (vutrisiran) across transthyretin amyloidosis (ATTR)
New Auction Record Set as Falcon Sells for AED 1.5 Million at ADIHEX 202629.8.2026 23:54:00 CEST | Press release
Qarmousha Pure Ultra White falcon sells for AED 1.5 million at the Abu Dhabi International Hunting and Equestrian Exhibition 2026 (ADIHEX) falcon auction Under the patronage of His Highness Sheikh Hamdan bin Zayed Al Nahyan, Ruler’s Representative in Al Dhafra Region and Chairman of the Emirates Falconers’ Club, the fifth auction held as part of the 23rd edition of the Abu Dhabi International Hunting and Equestrian Exhibition (ADIHEX) 2026 attracted remarkable turnout, culminating in the sale of a Qarmousha Pure Ultra White falcon for AED 1.5 million (USD 408,000). The sale marks the highest price achieved at any auction during this year’s edition of the exhibition. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260829032621/en/ Qarmousha Pure Ultra White (Photo: AETOSWire) This forms part of the largest auction programme in the exhibition’s history, held under the theme “A Legacy of Pride,” organised by ADNEC Group, a Modon
Takeda Receives U.S. FDA Approval of MIMRYLO™ (rusfertide), Marking a Potential Shift in the Treatment Paradigm for Polycythemia Vera29.8.2026 00:40:00 CEST | Press release
MIMRYLO, a First-in-Class Medicine with a Unique Mechanism of Action, is Approved for the Treatment of Erythrocytosis in Adults with Polycythemia Vera (PV)MIMRYLO Has Been Shown to Maintain Hematocrit Control, the Primary Treatment Goal in PV, as Well as Reduce Phlebotomy Burden and Improve FatigueApproval Supported by Phase 3 VERIFY Results Showing 76.9% of Patients Achieved Clinical Response During Weeks 20-32 Takeda (TSE:4502/NYSE:TAK)announced U.S. Food and Drug Administration (FDA) approval of the New Drug Application (NDA)* for MIMRYLO™ (rusfertide) for the treatment of erythrocytosis in adults with polycythemia vera (PV), a blood cancer. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260824773270/en/ MIMRYLO Logo MIMRYLO is a first-in-class hepcidin mimetic designed to regulate iron distribution in the body and red blood cell overproduction to control hematocrit levels, which is the ratio of red blood cells to the tot
Rigaku and Tohoku University Establish a New Research Institute for X-Ray Metrology28.8.2026 16:00:00 CEST | Press release
Rigaku Corporation, a group company of Rigaku Holdings and a global solutions partner for X-ray analytical systems (Head Office: Akishima, Tokyo; President and CEO: Jun Kawakami; “Rigaku”), and Tohoku University (Sendai, Miyagi; President: Teiji Tominaga; “Tohoku University”) have established the Rigaku-Tohoku University Co-Creation Research Institute for X-ray Metrology: Beyond The Limits (the “Institute”) at Tohoku University on August 1, 2026. The Institute will advance X-ray metrology technology, develop new metrology methods, and foster the next generation of researchers through an initial three-year collaboration, with the possibility of extension based on its achievements. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260828688510/en/ Inside the Institute As semiconductors become smaller, more multilayered, and incorporate a wider range of materials, manufacturing processes are becoming increasingly complex. X-ray me
BLK: Portfolio Company of Enry’s Island S.p.A., Lists on Euronext Dublin28.8.2026 15:34:00 CEST | Press release
Enry’s Island S.p.A. (WBAG:EIOS), an international venture builder with headquarters in the Tremiti Islands and the Metaverse, announces that BLK Global PLC, one of the portfolio companies within its ecosystem, has successfully completed its admission to trading on Euronext Access Dublin. Trading in the company’s shares commenced on Friday, July 31, 2026, under ticker BLKX and ISIN GB00BPSKS130. BLK was one of the thousands of applications received by Enry’s Island which, following an assessment process based on the Enry’s Model, was selected for a one-year incubation and acceleration programme. The programme supported the company through its subsequent growth stages, ultimately leading to its current stock market listing. Alessandro Pacciana, Investor Relations Manager of Enry’s Island S.p.A., said: “BLK’s listing is the second stock market listing in two years among Enry’s Island’s portfolio companies, while Enry’s Island itself is the world’s first listed venture builder. We are 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