Cube Click has received approval from the FDA for Smile Dx, its flagship medical device.
Smile Dx is an AI-powered diagnostic platform that can identify caries, root canals and periodontal disease at the radiographic pixel level, according to a June 19 news release from Cube Click.
The AI program led to a 19% improvement in diagnostic detection of caries and root canal pathologies, according to multiple clinical studies.
Smile Dx is the only FDA-approved system for detecting primary, secondary, and gross caries, the release said.
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