01 June 2022

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Overjet wins FDA nod for cavity detection software

Katherine E. Pfaff

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Dental AI solution firm, Overjet, won FDA 510(k) clearance for the company’s Caries Assist software. The AI-backed software detects dental cavities and outlines them as an assist during patient treatment and consultation. 

"This milestone is a demonstration of our strong commitment to complying with the highest quality standards and regulatory requirements," said Dr. Adam Odeh, head of the regulatory team at Overjet. "I'm very proud of our regulatory team, and growing team of engineers and clinicians. Together, we've been able to expand the versatility of our platform with a strong foundation in research. It's clear that everyone at Overjet is deeply dedicated to bringing this technology to the tens of thousands of clinicians and millions of patients in the US, and I'm excited to be part of this journey."

Overjet’s Caries Assist platform empowers dental professionals to find cavities with high accuracy that does not miss the lesions. The software was validated with more than 7,000 surfaces of teeth. According to results from testing by the company, the technology helped dentists using the software to identify 32% more caries than without the software.

“Since our inception in 2018, we have been on a quest to improve oral health by creating a future that is clinically precise, efficient, and patient-centric,” said Dr. Wardah Inam, co-founder and chief executive officer of Overjet. “With this clearance we are spearheading the transformation with innovative solutions for an industry that collectively wants better patient outcomes. With our Caries Assist, we are here to make a positive impact on the health of millions of Americans.”

The clearance is the second for the company after their Dental Assist technology, that provides periodontal disease bone level measurement from x-ray, was approved in 2021. 

Source: https://www.prnewswire.com/news-releases/overjet-receives-second-fda-clearance-adding-overjet-caries-assist-to-the-industrys-1-dental-ai-platform-301547447.html