FDA Approves First Artificial Intelligence Software to Evaluate Dental Radiographs

Pearl, a dental AI solutions company, today announced that the US Food and Drug Administration (FDA) has approved its AI-powered, real-time pathology detection solution software to help dentists accurately identify a wide range of common dental conditions. After Pearl’s “Second Opinion” received FDA clearance in March and “VideaHealth” received FDA clearance in May, “Diagnocat” has now received IRB committee approval in the US. In the first half of 2022, the fact that more than one high-investment company has passed the inspections of a developed country such as the USA, which has FDA approval, shows how close we are to artificial intelligence being effective in every aspect of dentists’ routine practices. The acceptance of AI programs in many major countries marks a significant step forward for dental technologies. Many software programs are now ready for use by dentists in North America, Europe, Australia and many other countries, adding US FDA clearances to the European CE, Canadian MDEL, UAE Ministry of Health, Australian TGA and New Zealand MEDSAFE clearances. AI systems support dentists in radiographic examinations to identify and analyze important pathological and non-pathological findings, including dental caries, discrepancies in the margins of existing restorations, calculus, periapical lesions, crowns, fillings, root canals, prosthetic restorations and implants.

When a periapical, orthopantomograph or CBCT image is acquired in a dental office, the software immediately displays the images and the detected conditions on monitors in the operating room, giving dentists a clearer view of their patients’ oral health and enabling patients to better understand their dentists’ findings. Another motivation for this software is the continuing education of dentists who have graduated from dental schools. Most of the approved software exceeded the FDA’s stringent efficacy requirements in four separate clinical trials, each involving a radiographic dataset of more than 2,000 images and an evaluation group of nearly 100 experienced dentists and oral, dental and maxillofacial radiologists. The tests showed that dentists using one of these software programs, Second Opinion®, detected 36% more lesions than dentists without the support of any artificial intelligence software. Cambron Carter, Pearl’s Chief Technology Officer and co-founder, said that while their software belongs to the group of FDA-approved CADe medical systems already in use for radiologically driven tasks such as lung nodule detection and mammography interpretation, cutting-edge algorithms that currently help detect cancerous lesions can now be applied to detect much more common dental pathologies. For the future of dentistry, artificial intelligence software is likely to significantly improve standards.