FDA plays tooth fairy, awards clearance to VideaHealth's cavity-spotting AI

The tooth fairy isn’t the only one granting dentistry-related wishes. The FDA bestowed a 510(k) clearance upon an artificial intelligence algorithm from VideaHealth that can help dentists identify cavities in patient X-rays.

The AI was built and trained using VideaHealth’s extensive database of dental X-rays, the Videa Factory, which the company says comprises the dental industry’s most diverse data set. It spans more than 100 million data points collected from dental service organizations, insurance companies, clearinghouses and universities.

According to clinical trial results that were submitted to the FDA to earn the agency’s OK, the AI helped reduce the number of caries lesions dentists missed by 43%. It also cut back on their incorrect diagnoses by about 15%.

“Our biggest priority as a team is ensuring that our solution is effective across diverse patient populations and helps dentists deliver the most accurate diagnoses,” said Florian Hillen, CEO and founder of VideaHealth. “This paves the way for more appropriate dental treatment recommendations and the opportunity for dentists to foster deeper patient engagement.”

The Massachusetts-based startup’s regulatory win came shortly after it hit another milestone: the close of its series A financing.

VideaHealth announced the funding round at the end of March, after raising a total of $20 million—which brough its lifetime fundraising tally to $26.4 million. Spark Capital led the round, while existing backers Zetta Venture Partners and Pillar VC also chipped in.

At the time, the company said it would use the new influx of cash to “massively expand” its AI-powered diagnostics to dentists across the U.S. Driving that expansion is VideaHealth’s current goal to become the core AI solution for more than 6,750 dental practices by the end of next year, which would represent about 3.5% of all practices in the U.S.

The dental industry has certainly been brushing up its technological abilities as of late. In the months before VideaHealth snagged its FDA clearance, other dental AI developers like Overjet and Pearl racked up agency nods of their own.

Overjet’s Dental Assist software, cleared last May, uses deep learning AI to automatically measure bone loss in X-rays. The real-time measurements can then be used to significantly speed up the amount of time it takes for dentists to diagnose and begin treating periodontal disease, which traditionally requires close manual analysis of X-rays to identify.

And this past March, the FDA greenlighted Pearl’s Second Opinion solution, which relies on computer vision AI to spot conditions like cavities, tartar and inflammation while also highlighting crowns, fillings, root canals, bridges, implants and more to help dentists keep tabs on them.