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
Angelalign Technology Inc. (6699.HK) Applauds European Court Rejection of Patent Infringement Claim12.5.2026 20:39:00 EEST | Press release
Angelalign Technology Inc. (6699.HK) (“Angel”) (http://www.angelaligner.com) today said it was grateful that the Local Division Düsseldorf (Germany) of the Unified Patent Court rejected a request by Align Technology Inc. (ALGN) for Angel to cease and desist from using its A7 Premolar Extraction Solution. Angel denied that the A7 tooth movement protocol infringes any patents as alleged by Align Technology Inc. (ALGN). The court rejected Align’s request for Angel to preliminarily cease its use of the feature, a decision Angel applauded. “We respect the Düsseldorf Local Division’s ruling and will continue to make our case that Angel has not violated any valid patents,” said Dr. Arno Riße, Angel’s attorney at the Arnold Ruess law firm of Düsseldorf. “We are grateful that the court decided not to grant Align's request for preliminary measures. Angel takes intellectual property rights seriously and is careful not to infringe on legitimate patents.” “We categorically deny the allegations of i
Bharat Forge Signs Long-Term Contract with Embraer for Landing Gear Forgings12.5.2026 19:38:00 EEST | Press release
Bharat Forge Ltd. (BFL) (BSE: 500493, NSE: BHARATFORG), a global leader in advanced forging and precision engineering, today announced a long-term contract with Embraer for the manufacturing and supply of critical landing gear forgings. With this milestone, Bharat Forge becomes the first Indian supplier to join Embraer’s global aerospace supply chain for forged components. Under the agreement, Bharat Forge will supply high-integrity forged components for landing gear systems across Embraer’s commercial and Defence aircraft programs. This engagement establishes a strategic partnership anchored in advanced manufacturing capabilities, precision engineering, and proven expertise in delivering complex, safety-critical components for global aerospace platforms. The long-term contract reflects a shared commitment to quality, reliability, and sustained collaboration, and reinforces Embraer’s confidence in Bharat Forge’s ability to meet stringent global certification standards while consistentl
De' Longhi Group - 6.6% Growth at Constant Exchange Rates and Accelerated Net Profit: Solid Results Fully Support Guidance12.5.2026 19:37:00 EEST | Press release
The Board of Directors of De' Longhi S.p.A. approved the consolidated results 1for the first quarter of 2026: In the first quarter the Group achieved: revenues of € 777.7 million, up 3% (+6.6% at constant exchange rates); adjusted 2Ebitda of € 125.9 million, equal to 16.2% of revenues (15.4% in Q1-25); net profit (pertaining to the Group) of € 61.7 million, equal to 7.9% of revenues and up 7.5% compared to the previous year; net financial position at the end of March 2026 of € 720.5 million. CEO Fabio de' Longhi commented: “The start of 2026 was marked by solid revenue growth of 6.6% at constant exchange rates, continuing the excellent performance achieved in recent years. The professional division's strong expansion sustained its momentum, with revenue growing by over 40% and now representing approximately 18% of total quarterly turnover. Simultaneously, we are pleased with the positive organic performance of the household division, which resumed its growth trajectory after successful
Multi-Color Corporation Successfully Completes Comprehensive Financial Restructuring12.5.2026 19:09:00 EEST | Press release
Multi-Color Corporation ("MCC" or the "Company") today announced the successful completion of the Company’s financial restructuring process and emergence from its prepackaged Chapter 11 process. The Company’s prepackaged restructuring reduced net debt by approximately $3.8 billion, reduced annualized cash interest expense by more than $330 million, and extended long-term debt maturities to 2033. More than 99% of voting stakeholders voted to accept MCC’s Plan of Reorganization. Upon emergence, MCC also received a significant $889 million new common and preferred equity investment from CD&R and a group of MCC’s existing secured lenders to support MCC’s long-term growth and investment. "Today marks a significant milestone for MCC, as well as our customers, teammates, and partners who have supported us throughout this process,” said Hassan Rmaile, President and Chief Executive Officer of MCC. “Over the last several months, we continued to diligently serve and win clients, sharpened our ope
New Cessna Caravans to Boost USDA’s Fight Against Crop-Damaging Insects12.5.2026 18:00:00 EEST | Press release
Textron Aviation Inc., a Textron Inc. (NYSE: TXT) company, today announced that the U.S. Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS) has ordered three Cessna Caravan aircraft to support its sterile insect release program protecting citrus crops along the Rio Grande River in southern Texas. The new aircraft are expected to be delivered in 2027. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260512676348/en/ Mission-Ready: The Cessna Caravan joins USDA’s fight to protect Texas citrus from invasive pests APHIS will use the Caravans to carry and release sterile insects that help prevent the spread of destructive pests, including fruit flies. The environmentally friendly technique helps safeguard fruit-bearing trees, reduce crop damage and protect agricultural industries that rely on healthy harvests. “These aircraft will help APHIS reach remote areas and carry out their important mission o
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