Pearl, a dental company specialised in technology-assisted dental care, has announced that their artificial intelligence (AI)-driven solution, Second Opinion, has been cleared by the US Food and Drug Administration (FDA) to detect numerous conditions in dental x-rays.
According to Pearl, Second Opinion is now the “only” AI-driven computer-aided clinical radiology solution available to dentists throughout North America, Europe, Australia and other parts of the world.
“This clearance is a major milestone not only for our team and for the many dentists, advisors and partners who have contributed to Second Opinion’s development, but also for dentistry itself,” said Ophir Tanz, CEO and founder of Pearl. “AI is a paradigm-shifting technology that will add value across the entire healthcare continuum. Because x-rays are a regular part of every dental patient’s experience, the first place most people will encounter the power of medical AI technology will be in their dentist’s chair. Second Opinion’s FDA clearance has made that possible.”
Pearl’s system supports dental professionals in their review of radiographs by applying computer vision to identify and highlight key pathologic and non-pathologic findings, including dental caries, discrepancies at the margin of existing restorations, calculus, periapical radiolucency, crowns, fillings, root canals, bridges and implants. When x-rays are captured in a dental office, Second Opinion displays the images and any detected conditions on monitors in the operatory, giving dentists sharper vision into their patients’ oral health and giving patients greater understanding of their dentist’s findings.
Pearl reported that Second Opinion exceeded the FDA’s stringent efficacy requirements across four separate clinical studies, each featuring a radiographic dataset of over 2,000 images and a reader group of 86 expert dentists and dental radiologists. The tests found that study participants reading x-rays with the assistance of Pearl’s AI system accurately identified “36% more lesions” than those without AI assistance did.
“Second Opinion now joins a family of FDA-cleared CADe medical systems already in use for radiologically driven tasks such as lung nodule detection and mammography interpretation,” said Cambron Carter, CTO and co-founder of Pearl. “State-of-the-art algorithms that currently assist in the detection of cancerous lesions can now be applied to detect many more frequently occurring dental diseases. The standard of care in dentistry is about to level up.”