FDA Clears Pearl’s Platform for AI-Assisted Pathology Detection on Panoramic Radiographs

Pearl has won U.S. Food and Drug Administration (FDA) 510(k) clearance for artificial intelligence (AI)-powered detection of dental pathologies on panoramic radiographs. The authorization expands Pearl’s clinically validated radiologic AI technology to the most widely captured extraoral imaging modality in dentistry, and is now available to Second Opinion users in the United States and internationally.

Pearl’s Second Opinion real-time chairside pathology detection platform is now cleared to identify and highlight suspected caries, periapical radiolucencies, and impacted third molars on panoramic radiographs. Panoramic radiographs present a broad anatomical view that can reveal a wide range of dental and maxillofacial conditions—but their complexity and anatomical distortion can make consistent and accurate pathology detection difficult. This latest FDA clearance validates the performance of Pearl’s radiologic AI applied to one of dentistry’s most diagnostically challenging imaging formats, according to the company.

“Panoramic x-rays are increasingly popular because they capture the full mouth with lower radiation than a traditional full-mouth X-ray series, but they remain one of the hardest types of dental X-ray to read reliably,” Pearl Founder/CEO Ophir Tanz stated. “AI brings greater clarity and certainty to pano interpretation. Patients benefit as well: Diagnoses are easier to understand when findings are clearly highlighted and labeled. Although panoramic X-ray adoption in the U.S. still trails the U.K. and Europe, this FDA clearance affirms the strength of our technology and moves the industry closer to universal AI support across dental radiology.”

The FDA clearance is supported by extensive clinical validation, including a standalone performance study and a fully crossed multi-reader, multi-case (MRMC) trial demonstrating that Second Opinion significantly improves detection of caries, periapical radiolucencies, and impacted third molars. Across all study subgroups—including gender, geography, and imaging device type—the AI maintained stable, unbiased performance.

For current Second Opinion users in the United States and internationally, panoramic AI support is available both within Pearl’s standalone software and across dozens of imaging and practice management systems where Second Opinion is natively integrated to support seamless adoption within existing clinical workflows.

Pearl is an AI-driven company committed to enhancing patient care in dentistry. Founded in 2019 by a team with decades of experience developing successful, enterprise-grade computer vision solutions, Pearl introduced the first FDA-cleared AI capable of reading and instantly identifying diseases in dental X-rays. With regulatory clearance in 120 countries, Pearl’s AI assists dentists in making precise clinical decisions and effectively communicating with patients, thereby transforming the dental care experience worldwide.