Business Wire

DENTALMONITORING

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

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/

To view this piece of content from mms.businesswire.com, please give your consent at the top of this page.

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)

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

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

Business Wire
Business Wire
101 California Street, 20th Floor
CA 94111 San Francisco

http://businesswire.com
DK

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

VSO Unveils VCP v1.0, a First-of-Its-Kind Cryptographic Audit Protocol to Restore Trust in AI-Driven Markets28.11.2025 06:30:00 CET | Press release

New open standard replaces opaque server logs with mathematically verifiable evidence, helping market participants meet EU AI Act and MiFID II transparency requirements The VeritasChain Standards Organization (VSO), an independent international standards body, today announced the global release of VeritasChain Protocol (VCP) v1.0, an open cryptographic audit protocol designed to provide mathematically provable transparency for AI‑driven and algorithmic trading systems. VCP replaces mutable server logs with a tamper‑evident chain of cryptographic evidence, enabling regulators, brokers, exchanges and trading firms to move from trust‑based oversight to verification‑based supervision. Why This Matters Now The launch of VCP v1.0 comes at a pivotal moment for global market infrastructure: More than 80 proprietary trading firms collapsed between 2024 and 2025 amid regulatory scrutiny, opaque execution models and frozen payout disputes, leaving a trust gap between traders and platforms. Regula

Andersen Consulting styrker sine kompetencer med BMA27.11.2025 22:48:00 CET | Pressemeddelelse

Andersen Consulting udvider sine kompetencer inden for bæredygtighed og virksomhedsforandring gennem en samarbejdsaftale med BMA, der er et sydafrikansk firma, som arbejder for at styrke konkurrenceevnen i fremstillingsindustrien og fremme inkluderende industriel vækst. BMA, der blev etableret for mere end to årtier siden, arbejder på tværs af produktionsværdikæder – fra producenter til deres kunder – sammen med myndigheder og udviklingsagenturer for at fremme bæredygtig industriel konkurrenceevne. Gennem sine sektorfokuserede industrielle klynger leverer firmaet integrerede tjenester inden for industriel politik og strategisk udvikling, værdikædestrategi, produktionskonkurrenceevne og lean-rådgivning, reduktion af CO2-udledning samt udvikling af små og mellemstore virksomheder og samler interessenter omkring fælles prioriteter og skalerbare, langsigtede løsninger. "Bæredygtig produktion handler om mere end effektivitet. Det drejer sig om at skabe økosystemer, der er regenerative, resi

Stronghold’s SHx Token Lists on Uphold27.11.2025 16:00:00 CET | Press release

Multi-Chain Expansion Accelerates With New Listing on a Trusted Platform Supporting Both Stellar and Ethereum Stronghold announced that its SHx token is now available for retail users to trade on Uphold, the global multi-asset digital money platform known for its transparency, regulatory alignment, and seamless support for assets across both the Stellar and Ethereum networks. The listing marks a major milestone for SHx, expanding access for users and businesses who rely on Stronghold’s token for payments, settlements, and governance participation. "Uphold is one of the only platforms that provides seamless support for both Stellar and Ethereum-based tokens, making it a perfect fit for SHx as we grow our multi-chain ecosystem. This listing was championed by our community, and we’re thrilled to deliver on a request that so many SHx holders have been asking for." — Tammy Camp, CEO & Co-Founder, Stronghold SHx is Stronghold’s native utility token, powering interoperable payments, DeFi-base

Wipro to Power Odido’s Digital Future Through AI-enabled End-to-End IT Modernization27.11.2025 14:22:00 CET | Press release

The multi-year engagement marks a significant shift in Odido’s IT strategywith Wipro bringing deep domain expertise, AI-powered delivery, and a design-led approach to drive innovation Wipro Limited (NYSE: WIT, BSE: 507685, NSE: WIPRO), a leading AI-powered technology services and consulting company, today announced a multi-year engagement with Odido Netherlands B.V.* to transform its IT landscape and enhance customer experience across their enterprise and consumer segments. By combining AI and deep consulting expertise, Wipro will help Odido improve customer engagement and satisfaction, improve productivity, and streamline operations to reduce costs. A key highlight of this multi-year engagement is the use of a self-funded model, where productivity-driven savings are reinvested to continuously fund new digital initiatives, ensuring that innovation remains both sustainable and scalable. As part of the engagement, Wipro will lead a full-scale modernization of Odido’s digital and enterpri

Klarna Set to Take off With Lufthansa Group, Bringing Flexible Payments to Travellers Across Europe and the U.S.27.11.2025 14:00:00 CET | Press release

Klarna, the global digital bank and flexible payments provider, today announces a new multi-market partnership with Lufthansa Group, Europe’s leading airline group. The new agreement is facilitated by Klarna’s integration with Adyen, the financial technology platform of choice for leading businesses. From November, Lufthansa Group customers will be able to choose Klarna’s flexible payment options at checkout when booking travel experiences. This new integration gives travellers greater control and convenience by offering the choice to pay in full, pay later, or spread the cost of their journey over time. The new options will be available first to customers in Austria, Belgium, Denmark, Finland, Germany, the Netherlands, Norway, Sweden, Switzerland, and the United States. “Travel is one of the most meaningful investments people make,” said David Sykes, Chief Commercial Officer at Klarna. “Together, we’re giving travellers the confidence to book their trips their way—with more flexibilit

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
World GlobeA line styled icon from Orion Icon Library.HiddenA line styled icon from Orion Icon Library.Eye