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Pearl Receives Industry-First Regulatory Certification for Comprehensive Dental Pathology Detection in European Markets
May 25, 2021
Pearl Receives Industry-First Regulatory Certification for Comprehensive Dental Pathology Detection in European Markets
The CE mark opens the European market to Pearl's flagship AI solution Second Opinion®--a patient-facing radiologic aid to elevate clinical excellence and build patient trust in dentistry

LOS ANGELES, May 25, 2021 -- Pearl, the leader in AI solutions for efficiency, accuracy, and consistency in dental care, today announced that it has been awarded CE-certification for its Second Opinion® AI solution to assist dentists in radiologic detection of dental pathologies. Second Opinion® is the first device of its kind to receive CE-marking for detecting a full range of dental conditions in dental x-rays. The CE mark signals conformity with patient and user safety standards within the European Economic Area––a regulatory requisite allowing Pearl to release Second Opinion® in the European market without restrictions.

"Second Opinion® will deliver the obvious benefits of a consistent, higher standard of care and it will also bring the second-order benefits –– more dental patients, higher case acceptance and improved communication –– that drive growth for the entire dental category."

Quality dental care begins with accurate x-ray diagnosis. The problem of widespread variance in radiologic interpretation among dentists –– observed anecdotally and demonstrated in research -– has been a primary impediment to patient trust in dental care. Trust is further undermined by a regular cadence of published accounts of fraud and other forms of impropriety perpetrated by rogue dentists.

Pearl was founded in part to narrow that deficit with a range of patented computer vision technologies that bring transparency and objectivity to diagnostic radiology.

Second Opinion® applies those technologies to detect and measure a comprehensive array of pathologies, existing restorations and natural anatomy in dental x-rays. The system instantly analyzes x-rays upon capture, allowing dentists conducting dental exams to review Second Opinion® detections overlaid on the x-ray image and display them for patients on exam room monitors.

Using the AI as a second set of eyes, dentists help ensure the reliability of their diagnostic findings. Then, showing patients the Second Opinion® detection, they fortify patient confidence that treatment recommendations are supported by the AI's objective analysis.

"To deliver the best oral health outcomes, as a practitioner I need patients to have faith in me and I need to have faith in my diagnoses," explained Dr. Kyle Stanley, a practicing dentist and Pearl's Chief Clinical Officer. "We developed Second Opinion® to take faith out of both sides of that equation. Dentists will always have the last word, but our clinical judgement becomes more accurate and more consistent when we're collaborating with AI."

According to Pearl founder and CEO, Ophir Tanz, patients in EU nations can soon expect the assurance of an AI-aided diagnosis when they visit the dentist.

"The moment dentists and patients experience Second Opinion®, they'll understand why we've been so vocal about AI's potential to revolutionize dentistry," Tanz said. "Second Opinion® will deliver the obvious benefits of a consistent, higher standard of care and it will also bring the second-order benefits –– more dental patients, higher case acceptance and improved communication –– that drive growth for the entire dental category."

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