DentalMonitoring Receives De Novo Approval From the FDA

Orthodontic treatment remote monitoring company DentalMonitoring® has received De Novo approval from the U.S. Food and Drug Administration (FDA) for the DentalMonitoring solution to be used by orthodontists.

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

The medical device software uses image processing algorithms to analyze pictures of the oral cavity (scans). Designed to optimize clinical care, scans are taken using the DM App, a smartphone, and the manufacturer’s proprietary hardware products.

With this De Novo approval, DentalMonitoring is also introducing the innovative SmartSTL™ feature to North American orthodontist customers. With SmartSTL, clinicians can request updated STL files via the DentalMonitoring dashboard without bringing the patient back into the office.

The software solution is designed to provide additional information compared to traditional orthodontic treatment follow-up. It is an additional asset to ensure patient compliance to orthodontic treatment requirements. With DentalMonitoring, clinicians receive an elevated level of insight into treatment progress and their patients experience increased convenience. Automated notifications and in-app communication with practice staff increase patient accountability and enhance communication between patients, healthcare providers, and caregivers, the company states.

DentalMonitoring is indicated for use for patients over the age of 6 and reports results solely on permanent teeth.

“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,” Philippe Salah, CEO and co-founder of DentalMonitoring, says in a press release.

Since 2012, only 4 De Novos have been granted by the FDA Dental panel, and none were software-based devices. 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, the company says. With the grant of this De Novo and the creation of a new regulatory category, DentalMonitoring is setting the stage for future innovations in the software as a medical device in the dental field category.