▾ G11 Media Network: | ChannelCity | ImpresaCity | SecurityOpenLab | GreenCity | Italian Channel Awards | Italian Project Awards | ...
InnovationOpenLab

DentalMonitoring Sets New Standard in Orthodontic Remote Monitoring With EU-MDR Certification

#EUMDR--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...

Business Wire

PARIS: #EUMDR--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.

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)

https://www.bsigroup.com/globalassets/localfiles/zh-tw/medical_device/document/bsi-smart-support-mdd-mdr-comparison.pdf

 

Fonte: Business Wire

If you liked this article and want to stay up to date with news from InnovationOpenLab.com subscribe to ours Free newsletter.

Related news

Last News

Sparkle works on environmentally sustainable content distribution

The Italian company partners with MainStreaming for high-performance, energy-efficient video streaming

Fintech: Links tests the use of exponential technologies in the banking…

Links Management and Technology just concluded the testing phase of a research project focused on banking transformation

Axyon AI: Italian Artificial Intelligence for Finance applications

Axyon AI offers an AI platform specifically designed for asset management, with several interesting strengths for those approaching machine/deep learning…

Italian Artificial Intelligence tackles medical emergencies at sea

Mermaid-AI is a telehealth platform at sea based on a visor equipped with an AR, medical Artificial Intelligence algorithms, satellite communications…

Most read

Sparkle works on environmentally sustainable content distribution

The Italian company partners with MainStreaming for high-performance, energy-efficient video streaming

Blockchain Pioneer ChainUp Switches to Certinal for eSign and eForm

#BlockchainInnovation--Certinal eSign and eForms, a trailblazer in digital signature solutions, proudly announce their adoption by ChainUp, a leading…

Lucidea Announces SydneyDigital, the ILS for a Digital-First World

#AI--Lucidea has announced that SydneyEnterprise, the leading ILS leveraged daily by global clients for over 35 years, is now SydneyDigital. With SydneyDigital,…

Europe Thermal Countermeasure Market Analysis Report 2023-2033: Opportunities…

The "Europe Thermal Countermeasure Market: Focus on Platform, Product Type, Integration Type, and Country - Analysis and Forecast, 2023-2033" report has…

Newsletter signup

Join our mailing list to get weekly updates delivered to your inbox.

Sign me up!