World’s 1st AI software that reads dental X-rays gains FDA clearance

Pearl recently received FDA clearance for its Second Opinion software, the first in the world to read dental X-rays to identify oral health conditions, the artificial intelligence company said March 8. 

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Second Opinion can be used to detect several dental conditions, including caries, discrepancies at the margin of existing restorations, tooth tartar and periapical radiolucency.

Pearl said the software exceeded the FDA’s efficacy requirements in four separate clinical studies, accurately identifying 36 percent more lesions than X-rays without AI assistance.

The software also has clearance in Europe, Canada, United Arab Emirates, Australia and New Zealand.

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