DentalMonitoring has been granted De Novo approval by the US Food and Drug Administration (FDA) for its DentalMonitoring remote monitoring solution.

Based in France, DentalMonitoring is an artificial intelligence (AI)-driven remote monitoring company for orthodontic care. Its DentalMonitoring solution is designed to help orthodontists in improving clinical care.

DentalMonitoring is a medical device software that analyses images of the oral cavity using advanced image processing algorithms.

The solution captures the scans through the DM App, utilising a smartphone and the manufacturer’s proprietary hardware products.

DentalMonitoring is specifically indicated for patients aged six and more. It reports findings solely on permanent teeth.

According to the orthodontic care company, the product is intended to aid healthcare providers in monitoring dental and orthodontic treatments remotely, as well as overseeing oral health and treatment progress.  

The remote monitoring product’s results are expected to be used in supporting diagnosis and on a stand-alone basis for clinical judgment.

DentalMonitoring CEO and co-founder Philippe Salah said: “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 DentalMonitoring and marks the beginning of a new era in orthodontics.”

DentalMonitoring is said to offer a range of additional insights compared to conventional orthodontic follow-up methods. It also helps in ensuring patient compliance with orthodontic treatment protocols.  

Furthermore, the software provides clinicians with an increased understanding of treatment progress, while simultaneously offering patients greater convenience, DentalMonitoring said.

Additionally, the solution’s automated notifications and in-app communication with healthcare providers bolster patient accountability, facilitating improved communication.

In addition to the FDA clearance, the orthodontic care company will introduce the SmartSTL feature to orthodontist customers across North America.  

SmartSTL allows doctors to request updated STL files directly via the DentalMonitoring dashboard, thereby minimising the need for patients to revisit the office.

DentalMonitoring is said to be the first AI/machine learning-enabled software as a medical device (SaMD) in the field.