PARIS--(BUSINESS WIRE)--Nov 20, 2024--
DentalMonitoring, the leader in Artificial Intelligence (AI)-powered remote monitoring for orthodontics, has released a major software update introducing features and indications based on the company’s De Novo approval from the U.S. Food and Drug Administration (FDA) in May 2024. Used by orthodontists around the world to optimize clinical care, DentalMonitoring’s remote monitoring solution leverages advanced image processing algorithms to analyze intraoral remote scans during orthodontic treatment. Patients take these scans using the DentalMonitoring app on their smartphone with the ScanBox pro phone holder. The AI-powered software supports practitioners with clinical indications to remotely detect, track, and monitor orthodontic treatment progress for enhanced real-time decision-making, supporting personalized treatment and optimizing scheduling. This makes treatment more convenient for patients and increases clinical control for providers.
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DentalMonitoring performed an extensive clinical study program on over 2,650 patients across 29 sites in North America, which rendered more than 13,000 clinical results presented to the FDA to validate the safety and effectiveness of DentalMonitoring in monitoring intraoral conditions and treatment progress. A very limited number of studies in the dental field involve so many sites and patients, which shows at the same time the robustness of our performances and the magnitude of innovation brought by DentalMonitoring. FDA-validated indications include archwire and auxiliaries passivity, bracket debonding, open self-ligating clips, tie loss, aligner seats and unseats, retainer seats and unseats, button or attachment loss, black triangles, extraction space closure, midline deviation, anterior space closure, overbite, open bite, overjet, and canine class. Orthodontic professionals, supported by this De Novo approval, could rely even more on the efficiency of DentalMonitoring to track treatment progress between in-office appointments.
Through this FDA Approval, DentalMonitoring is also proud to introduce the innovative SmartSTL feature in the United States following its successful rollout across Europe. SmartSTL allows doctors to request updated STL files via the DentalMonitoring dashboard. This allows orthodontists to access production-ready STL files needed for creating midcourse aligner corrections or retainer creation without scheduling the patient for an intraoral scan as was previously the accepted industry standard.
“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. The De Novo FDA approval of this improved version of DentalMonitoring software is a key milestone for DentalMonitoring and makes DentalMonitoring the first and only Software as a Medical Device to monitor remotely orthodontic treatments,” says Philippe Salah, CEO and co-founder of DentalMonitoring.
DentalMonitoring supports orthodontists with useful clinical data and is not to be used as a replacement for orthodontic care. DentalMonitoring is indicated for use for patients over the age of 6 and reports results solely on permanent teeth.
About DentalMonitoring:
DentalMonitoring is transforming orthodontic care globally through our advanced AI-driven platform. Our mission is to empower orthodontic practitioners with precise, real-time treatment monitoring and decision-making tools. By enhancing the connection between clinicians and patients, we make it possible to optimize treatment outcomes and ensure high-quality, efficient, and personalized orthodontic experiences.
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