SOUTH AFRICA – The South African Health Products Regulatory Authority (SAHPRA) has authorized Pearl’s Second Opinion® to help dentists detect numerous conditions in x-rays of dental patients 12 and older.
Second Opinion® will help clinicians in South Africa to deliver findings in real-time for patient-facing display in the dental operatory and help dentists ensure the accuracy of their x-ray evaluations thus enabling them to better communicate diagnoses to patients.
Second Opinion® is a system developed by the global leader in dental artificial intelligence (AI) solutions Pearl to support dental professionals in their review of radiographs by applying computer vision to identify and highlight key pathologic and nonpathological findings.
Founded in 2019 by Ophir Tanz, Pearl is shaping the future of dental care by delivering dental AI and computer vision solutions that advance efficiency, accuracy, transparency, and patient care.
When x-rays are captured in a dental office, Second Opinion® immediately displays the images and any detected conditions on monitors in the operatory, giving dentists sharper vision into their patients’ oral health and giving patients greater understanding of their dentist’s findings.
Pearl notes that Second Opinion® is an AI-powered, real-time pathology detection solution to help dentists accurately identify a broad range of common dental conditions in patient x-rays.
Furthermore, Pearl’s system is the first and only FDA-cleared chairside AI software to help dentists detect numerous conditions in dental x-rays and the first to add European CE, Canadian MDEL, UAE Ministry of Health and Prevention, Australian TGA and New Zealand MEDSAFE clearances.
“Second Opinion® exceeded the FDA’s stringent efficacy requirements across four separate clinical studies, each featuring a radiographic dataset of over 2,000 images and a reader group of 86 expert dentists and dental radiologists,” Pearl confirms.
Pearl’s system applies computer vision technology to support clinicians in detecting dental caries(cavities), bone loss, discrepancies at the margin of existing restorations, calculus(tartar), periapical radiolucency, impactions, crowns, fillings, root canals, bridges, implants and more.
South Africa joins the United States, European Union, Canada, Australia, New Zealand, United Arab Emirates, Saudi Arabia and Brazil in the growing list of medical device authorizations for Second Opinion®.
Pearl announced that Second Opinion®, its chairside clinical artificial intelligence software, has received clearance from SAHPRA while confirming that dentists in South Africa can begin using Pearl’s Second Opinion®.
“We’re excited to bring to South African dentistry the clinical benefits that Second Opinion® is already delivering in so many other countries, its SAHPRA clearance is something that patients and practices in South Africa can smile about,” Founder of Pearl Ophir Tanz said in a press release.
Ophir Tanz emphasized that every dental practice in the world wants to deliver care with the greatest consistency, confidence and precision and every dental patient wants to know that the care they receive meets that exceptional standard, adding that Second Opinion® satisfies both of those desires.
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