FDA clears first AI-powered radiologic detection aid

Pearl’s Second Opinion has obtained clearance from the U.S. Food and Drug Administration (FDA), according to the company’s press release. Second Opinion is a radiologic detection aid powered by artificial intelligence (AI). It can purportedly help dentists identify a number of common dental conditions – including tooth decay, calculus, and root abscesses – in patient x-rays.

The company claimed Second Opinion as “the first and only chairside FDA-cleared” product of its kind.  

“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,” reads the press announcement.

“Second Opinion’s FDA clearance has made that possible.”

The product has already earned multiple clearances from international bodies for import standards and compliance, including: UAE Ministry of Health and Prevention, European CE, Canadian MDEL, New Zealand MEDSAFE and Australian TGA.

The FDA clearance for the AI-powered, real-time pathology detection solution “marks an important step forward for technology-assisted dental care”, said the company.

“Second Opinion is now the only AI-driven computer-aided clinical radiology solution available to dentists throughout North America, Europe, Australia and many other parts of the world”, reads the press information.

“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,” said Ophir Tanz, CEO and founder of Pearl.

“AI is a paradigm-shifting technology that will add value across the entire healthcare continuum.”

Pearl’s system applies computer vision to identify and highlight key pathologic and nonpathologic findings – including dental caries, discrepancies at the margin of existing restorations, calculus, periapical radiolucency, crowns, fillings, root canals, bridges and implants.

Second Opinion displays the x-ray images and any detected conditions on the monitor screens of the operatory, to facilitate AI-powered diagnostics and patient communication.

“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,” said Professor Dr. Markus Blatz, DMD.

“Its long-term impact on the field of clinical dentistry may be more important, however. We endeavour to establish a standard of care through instruction at dental school, but at some point our instruction stops. Second Opinion will help us maintain that standard and, over time, establish a more consistently rewarding patient experience.”

According to Pearl, Second Opinion exceeded the FDA’s efficacy requirements across four separate clinical studies. Each study featured a radiographic dataset of over 2,000 images and a reader group of 86 expert dentists and dental radiologists. The tests found the AI-assisted readings accurately identified 36% more lesions than those without AI assistance, said the company.

“Second Opinion now joins a family of FDA cleared CADe medical systems already in use for radiologically-driven tasks such as lung nodule detection and mammography interpretation,” said Cambron Carter, Pearl’s CTO and co-founder.

“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.”

Pearl is a US provider of dental AI solutions. Its AI driven software is currently used by radiograph manufacturers, dentists and dental service organizations across Europe, Canada, Australia, South America and the Middle East.