Pearl has announced that the US Food and Drug Administration (FDA) has granted 510(k) clearance for the use of artificial intelligence to assist in the detection of dental pathologies on panoramic radiographs. The clearance extends the company’s previously validated radiologic AI technology to panoramic imaging, the most commonly used extraoral radiographic modality in dentistry. The cleared functionality is available to users of the Second Opinion® platform in the United States and internationally.
With this clearance, Second Opinion is authorized to identify and visually indicate suspected caries, periapical radiolucencies, and impacted third molars on panoramic radiographs. Panoramic imaging provides a comprehensive view of the maxillofacial region, but anatomical overlap and image distortion can make interpretation variable. The FDA’s decision reflects an evaluation of the system’s performance in this diagnostically complex imaging format.
“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,” said Ophir Tanz, founder and CEO of Pearl. “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 clearance is supported by clinical validation data, including a standalone performance study and a fully crossed multi-reader, multi-case (MRMC) study. These evaluations demonstrated improved detection of the specified conditions when clinicians used the AI system. Performance consistency was observed across analyzed subgroups, including gender, geographic region, and imaging device type.
This authorization adds panoramic radiographs to the range of imaging modalities for which the platform has received FDA clearance, alongside bitewing, periapical, and cone-beam computed tomography (CBCT) images. Panoramic AI functionality is accessible through Pearl’s standalone software as well as through integrations with multiple imaging and practice management systems, allowing use within existing clinical workflows.
