FDA Clears AI Software to Read Dental X-Rays

Pearl’s Second Opinion is a chairside FDA-cleared AI radiologic detection aid that can help dentists identify numerous common dental conditions, including tooth decay, calculus and root abscesses.
Posted: March 21, 2022
Edited by Dentaltown staff

LOS ANGELES—Pearl, a provider of dental AI solutions, announced that the United States Food and Drug Administration (FDA) has cleared its AI-powered, real-time pathology detection solution Second Opinion to help dentists accurately identify a broad range of common dental conditions in patient X-rays.


FDA Clears AI Software to Read Dental X-Rays


 
Second Opinion becomes the first AI-driven solution cleared to detect numerous conditions in dental X-rays, and the first to add US FDA clearance to European CE, Canadian MDEL, UAE Ministry of Health and Prevention, Australian TGA and New Zealand MEDSAFE clearances.

“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 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.”

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.

For more information, visit hellopearl.com/products/second-opinion.
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