VideaHealth Dental AI Solution Receives FDA 510(k) Clearance, Establishing Industry-wide Benchmark for Clinical Accuracy

Company ushers in a new era of transparency and efficiency by bringing to market the most diverse AI dental imaging dataset in the industry

VideaHealth, a dental AI pioneer, announced the U.S. Food and Drug Administration (FDA) has issued 510(k) clearance for Videa Caries Assist, an AI-powered dental caries (cavity) detection algorithm. VideaHealth surpassed the FDA’s exacting efficacy requirements by significantly aiding the analysis of radiographs instantly from the dentist’s chair.

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“Our biggest priority as a team is ensuring that our solution is effective across diverse patient populations and helps dentists deliver the most accurate diagnoses. This paves the way for more appropriate dental treatment recommendations and the opportunity for dentists to foster deeper patient engagement.”

In the FDA trial, the number of missed caries was 43% lower for dentists using Videa’s AI. Notably, the dentists using Videa’s AI also experienced a 15% average reduction in erroneous detections of caries lesions. All dentists in the trial, regardless of experience level, encountered caries detection capability improvements. These detection performance improvements enable more accurate diagnoses, better preventative care and substantial cost savings for patients by reducing unnecessary invasive treatments. A joint study with VideaHealth partner Heartland Dental revealed similar impacts on diagnostic improvements and treatment planning.

VideaHealth is disrupting a market that has remained largely unchanged for the past 30 years, providing greater transparency to patients, and is actively working to reduce AI bias in dentistry. The company’s breakthrough solution is built upon the Videa Factory, which houses the industry’s most diverse dataset with over 100 million data points from leading dental service organizations (DSOs), insurance companies, clearinghouses and universities. This helps the VideaHealth algorithms remain impartial and more fully represent the diversity of the U.S. population.

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Florian Hillen, leading industry AI researcher and founder and CEO of VideaHealth, said, “Our biggest priority as a team is ensuring that our solution is effective across diverse patient populations and helps dentists deliver the most accurate diagnoses. This paves the way for more appropriate dental treatment recommendations and the opportunity for dentists to foster deeper patient engagement.”

VideaHealth’s AI technology and seamless workflow integration radically accelerate and improve decision-making across the entire dental chain, unlocking the most economic and health value for providers, insurers and patients. With FDA clearance and funding from some of the world’s top-tier venture capital firms, VideaHealth is poised to support millions of patients through strategic partnerships with leading DSOs with the goal of ensuring every dental patient receives an accurate diagnosis and every provider captures efficiencies and faster reimbursements.

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