The FDA recently cleared Pearl’s Second Opinion® AI radiologic detection aid, a solution designed to help dentists accurately identify a broad range of common dental conditions in patient x-rays.
The system applies computer vision to identify and highlight key pathologic and nonpathologic findings, including dental caries, discrepancies at the margin of existing restorations, calculus, periapical radiolucency, crowns, fillings, root canals, bridges and implants, according to a press release.
Once x-rays are captured, Second Opinion immediately displays the images and any detected conditions on monitors in the operatory. This gives dentists a better look at what’s going on in the patient’s mouth and helps patients better understand the dentist’s findings, improving patient communication.
The solution exceeded the FDA’s efficacy requirements across four separate clinical studies, according to the release, each featuring a radiographic dataset of more than 2,000 images and a reader group of 86 expert dentists and dental radiologists. The tests showed advantages for readers using Second Opinion, including finding that study participants reading x-rays with the assistance of the AI system accurately identified 36% more lesions than those without AI assistance.
“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, according to the release. “AI is a paradigm-shifting technology that will add value across the entire health care 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.”
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