DentalMonitoring, an orthodontic software and AI company, earned De Novo approval from the FDA for a medical device software.
The software utilizes image processing algorithms to analyze dental scans using the DentalMontoring app, a smartphone and hardware products, according to a May 20 news release.
The analysis is intended to help dental professionals remotely monitor dental treatments, orthodontic treatments, oral health and treatment progress.
The product is to be used as a diagnostic aid and not the only information to be considered in clinical decision-making.
Since 2012, there have only been four De Novo approvals awarded by the FDA Dental panel, the release said.