DentalMonitoring has obtained EU Medical Device Regulation (EU-MDR) certification for its software.
The certification allows the company to affix the CE mark to its product, classifying it as a class IIa medical device.
Furthermore, the company will be able to set new standards in orthodontic remote monitoring.
DentalMonitoring CEO and co-founder Philippe Salah said: “I’m incredibly proud that DentalMonitoring has achieved EU MDR certification along with US/FDA DeNovo 510k clearance.
“Our AI-powered solutions are now recognised at the highest regulatory levels, enabling us to expand our reach and impact more lives with advanced dental technology.”
Utilising image processing algorithms, the DentalMonitoring software can analyse high-quality intraoral scans taken by patients with the DM App, a smartphone and hardware.
This technology enables healthcare professionals to monitor dental and orthodontic treatments, as well as oral health, from a distance.
DentalMonitoring Regulatory, Quality and Clinical Affairs director Arnaud Berthier said: “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.”
Furthermore, the medical device software provides weekly clinical updates that assist clinicians in diagnosis and treatment planning.
This innovation not only enhances the level of insight for healthcare providers but also offers patients the convenience of remote monitoring.
Automated notifications and in-app communication with practice staff are integral features of DentalMonitoring's software, fostering increased patient accountability.
Moreover, these tools improve the communication flow between patients and healthcare providers, promoting adherence to orthodontic treatment protocols.
