DentalMonitoring has secured De Novo approval from the US Food and Drug Administration (FDA) for its AI-powered remote orthodontic monitoring solution.
The authorisation allows orthodontists to utilise the DentalMonitoring medical device software to enhance clinical care.
The software employs advanced image processing algorithms to assess oral cavity images that are taken using the DM App, a smartphone, and the manufacturer’s hardware products.
DentalMonitoring’s software is designed to assist healthcare professionals in remotely tracking dental treatments, orthodontic treatments, oral health, and treatment progress.
The solution is indicated for patients above six and focuses on permanent teeth. It is intended to be used as a diagnostic aid rather than a standalone tool for clinical decision-making.
DentalMonitoring CEO and co-founder Philippe Salah said: “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.”
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The technology offers an additional layer of information beyond traditional orthodontic treatment follow-ups, ensuring patient adherence to treatment requirements. Clinicians gain a deeper understanding of treatment progress while patients benefit from the convenience of remote monitoring.
It also offers automated notifications and in-app communication with practice staff to improve patient engagement and foster better communication between healthcare providers, patients and caregivers.
DentalMonitoring is also introducing SmartSTL to its orthodontist customers in North America.
This feature allows doctors to request updated STL files directly from the DentalMonitoring dashboard, eliminating the need for patients to return to the office.
Last year, DentalMonitoring launched ScanAssist, an AI-guided scan for orthodontics.
The device helps patients complete their scans while aiming to provide a fun and engaging patient experience.
