Overjet nets FDA clearance for gum-disease-spotting deep learning software

Dentist and patient
The Dental Assist deep learning software analyzes teeth X-rays to help dentists diagnose and treat periodontal disease more quickly and accurately. (Getty/SolisImages)

Say cheese: The FDA has authorized one of the first artificial-intelligence-based technologies for use in dentistry, a software platform from dental developer Overjet.

With the 510(k) clearance, Overjet will be able to market its Dental Assist software for clinical use, selling it directly to dental practices. The software is already employed by insurance companies to make claims processing more accurate and efficient.

“All clinicians can now have at their fingertips highly accurate software to detect and measure serious dental disease and clear AI visualizations to communicate with patients,” Wardah Inam, CEO and co-founder of Overjet, said in a release.

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Dental Assist uses deep-learning algorithms to measure bone loss in dental X-rays. Those measurements are then used to diagnose periodontal disease, which is estimated to affect nearly half of all U.S. adults. Almost 10% of the population have severe periodontitis, which can cause pain and tooth loss if left untreated.

Because Dental Assist’s analyses are performed in real time, dentists are able to begin treating gum disease much more quickly than with traditional methods, which require them to manually study X-rays to estimate bone levels.

The software has also been proven to be highly accurate. In a clinical study, Dental Assist’s measurements were compared to those of three dentists and an oral radiologist, resulting in an average disparity of less than one-third of a millimeter.

“We’re seeing dental AI software perform at the level of a team of trained dentists with accuracy closer than the width of a needle,” said Chris Balaban, Overjet’s clinical director. “These tools unlock the ability to track the progression of disease over time for each tooth and make the case for evidence-based treatment, supported by unbiased software and clear visuals for patients.”

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Overjet is developing other AI technologies to detect and diagnose even more dental conditions, including cavities, impacted teeth and tartar buildup. Its larger clinical intelligence platform also uses AI to automate administrative tasks in dental practices, such as spotting coding and billing errors and outlining a set process of diagnostic and treatment protocols for each patient visit.

The company’s first FDA clearance comes three years after it was incubated at the Harvard Innovation Labs by a group of scientists from MIT and the Harvard School of Dental Medicine.

In that time, it has raised more than $10 million to advance its AI-based software. Last June, Overjet closed a $7.85 million seed round that came from round leader Crosslink Capital and the MIT-exclusive E14 Fund.