FDA approval marks major step for Second Opinion AI software

Jeremy Booth, Dental Tribune International

Mon. 14. March 2022

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WEST HOLLYWOOD, Calif., US: Second Opinion, an artificial intelligence (AI) diagnostic tool that assists in dental radiography, has been cleared by the US Food and Drug Administration (FDA) for use by dental professionals in the country. This milestone follows the recent approval of the software by health regulators in Australia and New Zealand and the granting of the European CE mark. The software was developed by Pearl, and the company’s founder and CEO, Ophir Tanz, said that the clearance was a major step for dentists, who are now free to shift into the AI paradigm in their everyday clinical practice.

Pearl is a leader in developing AI solutions for use in dentistry, and its Second Opinion tool is a real-time pathology solution that assists dentists in accurately detecting and diagnosing common dental conditions using dental radiographs. A computer vision platform that can identify and measure an array of pathologies, the software highlights potential areas of interest and provides dentists with a second set of eyes.

The FDA cleared the software in early March, and a press release from Pearl explained that the agency’s strict efficacy requirements had been exceeded by the clinical studies that formed the basis of the company’s application for market approval.

In total, Pearl submitted four clinical studies to the healthcare regulator, and each of the studies featured a dataset of more than 2,000 images that were interpreted by dozens of expert dentists and radiologists. Pearl said that the studies showed clear advantages for the experts using Second Opinion software. Those who had used the AI software had identified 36% more lesions than those who had worked without AI assistance.

The company said that the FDA clearance marked an important step in the adoption of technology-assisted dental care. Tanz commented in the press release: “This clearance is a major milestone not only for our team and for the many dentists, advisors and partners who have contributed to Second Opinion’s development, but also for dentistry itself.” He explained that AI-assisted technology brought with it a paradigm-shift in dental technology that he said would add value across the entire healthcare sector. “Because x-rays are a regular part of every dental patient’s experience, the first place most people will encounter the power of medical AI technology will be in their dentist’s chair. Second Opinion’s FDA clearance has made that possible,” he added.

Prof. Markus Blatz, a key opinion leader in restorative dentistry and digital innovation, said in the press release: “The benefit that Pearl’s AI brings to patient communication in the dental operatory—and the trust that follows—cannot be overstated, and it is in that area that Second Opinion’s impact will be most immediately felt.”

Pearl’s co-founder and chief technology officer, Cambron Carter, added: “State of the art algorithms that currently assist in the detection of cancerous lesions can now be applied to detect many more frequently occurring dental diseases. The standard of care in dentistry is about to level up.”

Speaking to Dental Tribune International, Tanz predicted that, as dental patients reap the benefits of AI-assisted technology, dentistry itself would become a model for the rapid adoption of AI in other medical fields. “So, at the same time as today we welcome the future of AI-powered dentistry, we also welcome an AI-powered future for all of healthcare,” he said.

In October last year, Second Opinion was provided with market authorisation by Australia’s Therapeutic Goods Administration and New Zealand’s Medicines and Medical Devices Safety Authority. Earlier in 2021, it received the European CE marking, and it is already being used daily by dentists in North America, Europe, Australasia, South America and the Middle East.