Pearl, a 2022 Dental AI solutions company, announced today that the U.S. Food and Drug Administration (FDA) has approved its artificial intelligence-supported, real-time pathology detection software to assist dentists in accurately identifying various common dental conditions. Following Pearl’s “Second Opinion” approval in March and VideaHealth’s FDA clearance in May, Diagnocat has also obtained approval from the IRB committee in the United States. The fact that multiple high-investment companies have obtained FDA approvals in the first half of 2022 shows how close we are to seeing the effectiveness of artificial intelligence in various routine dental practices.
The acceptance of artificial intelligence programs in many major countries marks a significant milestone in dental technologies. Numerous software solutions have now obtained approvals from European CE, Canada MDEL, UAE Ministry of Health, Australia TGA, and New Zealand MEDSAFE, making them ready for use by dentists in North America, Europe, Australia, and many other countries.
Artificial intelligence systems support dentists in identifying and analyzing important pathological and non-pathological findings in radiographic examinations, including dental caries, discrepancies in existing restoration margins, calculus, periapical lesions, crowns, fillings, root canals, prosthetic restorations, and implants.
When periapical, orthopantomograph, or CBCT images are obtained in a dental office, these software solutions immediately display the images and detected conditions on monitors in the operating room, providing dentists with a clearer view of their patients’ oral health and helping patients better understand their dentists’ findings. Another motivation for these software solutions is to continue the education of dental graduates after completing their studies at dental faculties.
Most approved software solutions surpassed the rigorous effectiveness requirements of the FDA in four separate clinical studies, each consisting of over 2,000 radiographic images and involving an evaluation group of nearly 100 experienced dentists and oral, dental, and maxillofacial radiology experts. The tests showed that dentists using the Second Opinion® software detected 36% more lesions compared to dentists who did not use any artificial intelligence software.
Cambron Carter, Chief Technology Officer and co-founder of Pearl, stated that their software is now part of the FDA-approved CADe medical system group, which is already being used for tasks such as lung nodule detection and mammography interpretation, and that the latest technology algorithms assisting in the detection of cancerous lesions can now be applied to more common dental pathologies.
Artificial intelligence software seems to be set to significantly advance the standards for the future of dentistry.
