DentalMonitoring Obtains De Novo Approval

Posted: May 20, 2024
Edited by Orthotown staff

PARIS—DentalMonitoring, a leader in AI-powered remote monitoring for orthodontic treatment, has received De Novo approval from the U.S. Food and Drug Administration (FDA) for its solution to be used by orthodontists in optimizing clinical care.

The DentalMonitoring software uses image processing algorithms to analyze pictures of the oral cavity (hereinafter Scans). Scans are taken using the DM App, a smartphone and the manufacturer’s proprietary hardware products. The software is indicated for use for patients over the age of 6 and reports results solely on permanent teeth.

The product is designed to assist healthcare professionals in remotely monitoring dental treatments, orthodontic treatments, oral health and treatment progress. The results are intended to be used as an aid in diagnosis and not on a stand-alone basis for clinical decision-making.

DentalMonitoring provides additional information compared to traditional orthodontic treatment follow-up, aiming to ensure patient compliance with orthodontic treatment requirements. The software allows clinicians to gain a higher level of insight into treatment progress, while patients benefit from increased convenience. Automated notifications and in-app communication with practice staff enhance patient accountability and improve communication between patients, healthcare providers and caregivers.

With this FDA approval, DentalMonitoring will also introduce the SmartSTL feature to North American orthodontist customers. SmartSTL allows doctors to request updated STL files via the DentalMonitoring dashboard without bringing the patient back into the office.

“We are proud to be the new standard of care in orthodontics. This is a recognition of our 10 years of research and development in deep learning artificial intelligence. FDA approval of this improved version of DentalMonitoring software is a key milestone for our company and marks the beginning of a new era in orthodontics,” says Philippe Salah, CEO and co-founder of DentalMonitoring.

Since 2012, only four De Novos have been granted by the FDA dental panel. DentalMonitoring is the first artificial intelligence/machine learning-enabled software as a medical device in dentistry, establishing a classification within FDA dental regulation numbers and product codes.

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