We’re proud to share that SMILE Dx® has officially received FDA approval — a milestone that validates years of research, clinical rigor, and disciplined engineering. This clearance confirms that our AI-powered platform meets the highest standards for safety, accuracy, and real-world diagnostic performance.

FDA approval isn’t just a regulatory checkbox; it’s a powerful signal to clinicians, partners, and investors. It demonstrates that SMILE Dx® performs reliably across diverse radiographs and consistently identifies dental pathologies with precision — helping reduce missed disease and supporting more confident treatment planning.

This achievement opens the door to large-scale clinical deployment and strategic partnerships across DSOs, private practices, and dental technology ecosystems. It also positions SMILE Dx® for accelerated commercial growth, transforming our AI platform from a promising innovation into a market-ready, de-risked solution.

We’re just getting started — and this milestone marks the beginning of a new era in dental diagnostics.