Israel latest country to give regulatory clearance to Pearl’s flagship dental AI solution behind Brazil, Australia, and more

Pearl, the leader in AI solutions for efficiency, accuracy, and consistency in dental care, today announced that it has received clearance from Israel’s Ministry of Health, Medical Technology, Information and Research Division, for Second Opinion®, the first and most comprehensive AI-powered real-time pathology detection aid for dentists. This marks the latest in the solution’s series of international clearances, including CE-marking in Europe, MDEL for use in Canada, and TGA/MEDSAFE clearance in Australia and New Zealand. It is the US-based dental company’s second licensing in the Middle East following UAE clearance in 2021. Second Opinion®, which received FDA clearance in March of last year, helps dentists by automatically detecting a broad range of dental conditions in bitewing, periapical and panoramic radiographs of permanent teeth in patients 12 and older.

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Pearl’s Second Opinion® Cleared in Israel, Expanding Global Access to World’s Leading Dental AI Technology (Graphic: Business Wire)

“Second Opinion® is poised to bring a higher standard of care to Israeli dentistry, creating a more consistent and trusted dental experience for patients,” said Tel Aviv-based clinician and IJED board member Rafi Romano DMD, MSc. “AI is no longer just ‘nice to have’ but a ‘must’ in all medical diagnoses and treatment plans. Pearl’s technology is definitely a big jump for dentists worldwide – and in Israel particularly – and will not only assist patients who want a second opinion but will also upgrade the level of each dentist in every clinic.”

Second Opinion® applies computer vision technologies to detect a wide array of pathologies, existing restorations, and natural anatomy in dental radiographs. The system analyzes radiographs in real time, allowing dentists to display, review, add or reject the system’s detections while conducting exams. Dental professionals using Second Opinion® AI read x-rays 37% more accurately, leading to more effective treatment decisions and higher satisfaction and trust among patients.

“Quality dental treatment starts with quality radiology and Second Opinion® allows dentists to optimize their work as radiologists, enabling them to consistently deliver need-based care of the highest standard,” said Ophir Tanz, CEO and co-founder of Pearl. "With the clearance of our platform in Israel, we look forward to expanding our presence in such an important, tech-forward international hub and enabling better patient outcomes in global dentistry."

Dentists in Israel and other approved countries can learn more about Pearl’s Second Opinion® by visiting www.hellopearl.com/products/second-opinion.

About Pearl

Pearl is leading the global dental AI revolution with groundbreaking computer vision solutions that elevate efficiency, accuracy and the standard of care in dentistry. Founded in 2019 by Ophir Tanz, Pearl is backed by Craft Ventures and other leading venture capital firms. For more information or to request a demonstration, please visit https://www.hellopearl.com.

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