FDA smiles on 2nd cavity-spotting AI in a month with clearance for Overjet’s tech

FDA smiles on 2nd cavity-spotting AI in a month with clearance for Overjet’s tech

Not content to simply grin and bear it as another dental artificial intelligence developer, VideaHealth, snagged FDA clearance for cavity-spotting AI just a few weeks ago, Overjet has quickly followed suit.

The Boston-based startup announced Monday that it locked down a 510(k) clearance—its second in the last year—for its own AI technology to automatically detect cavities.

Like VideaHealth’s own AI—which, interestingly, shares the same name—Overjet’s Caries Assist system analyzes dental X-rays then highlights signs of tooth decay and caries lesions in the images. Both AI tools share a goal of reducing the number of cavities missed by dentists in manual inspections of X-ray scans.

In a study, Overjet put the AI to the test by showing it images of more than 7,000 tooth surfaces. With the help of the resulting analyses, the company said, dentists were able to increase the number of cavities identified by about 32% compared to the results of their purely manual diagnoses.

Those results are comparable to the performance of Videa Caries Assist, which was cleared by the FDA at the end of April. In a study of its own, VideaHealth said its AI helped dentists spot 43% more cavities that would otherwise have been overlooked.

The mintynfresh FDA clearance adds a second AI tool to Overjet’s repertoire. The tools are meant to be used together to make real-time diagnoses in the dental exam room.

The company’s first agency nod arrived almost exactly a year ago. It was bestowed upon the Dental Assist technology, which uses deep learning AI to measure bone loss, helping dentists identify cases of periodontal disease, a condition that’s estimated to affect almost half of all adults in the U.S.

“Overjet goes beyond specific AI algorithms to act as a chairside software-as-a-medical-device, enhancing clinical decision-making in dental practices around the country,” said Terri Dolan, D.D.S., Overjet’s chief dental officer. “By bringing both bone level measurement with periodontal disease and dental caries detection, as well as quantification for bone level and outline with caries, we enable comprehensive care to be delivered to the right patient with the right treatment at the right time.”

In the months after securing its first FDA nod, Overjet has stayed plenty busy. In August, it sank its teeth into a series A funding round that almost quadrupled its lifetime funding total.

General Catalyst and Insight Partners led the $27 million financing. They were joined by the E14 Fund, which backs startups linked to the Massachusetts Institute of Technology—like Overjet, which was founded by MIT scientists and Harvard University dentists and incubated at the Harvard Innovation Labs.

At the time, the company said it would use the funding to continue developing new AI tools and expand the reach of its technology to more dental clinics across the U.S.

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