Software/ platforms

Envista Obtains FDA Clearance for Assisted Intelligence Nerve Tracing

Envista Holdings Corporation (NYSE: NVST) (“Envista”) — Envista announced today the 510(k) Food and Drug Administration (FDA) clearance of its Assisted Intelligence (AI) mandibular nerve tracing feature in its image acquisition and diagnostic software platform DTX Studio Clinic.

The tracing of the mandibular nerve in modern dentistry is of high significance as it influences the available therapeutic options for the patient. The proper visualization of the nerve can prevent complications. When done manually, it is a task that can be both time-consuming and error prone. DTX’s AI capabilities supports clinicians as they perform this important task. 

This clearance complements a series of AI-powered functionality in DTX Studio Clinic. In 2017, Envista obtained FDA clearance for its AI-driven 3D virtual tooth setup algorithm. In 2020, a further clearance was received for automatic tooth position identification and automated sorting of full-mouth x-ray series. On March 25, the FDA cleared the third AI-focused 510(k) for the fully automated mandibular nerve tracing on CBCT scans.

Amir Aghdaei, Envista CEO, said, “This clearance is another important step towards our digital strategy of expanding the capabilities of our powerful, unified, and open dental diagnostic software platform DTX Studio Clinic. With its combination of a user-friendly interface and AI-driven functionality, DTX Studio Clinic reduces the time clinicians spend on time-consuming tasks, while simultaneously helping prevent complications and enabling increased focus on the patient. We are particularly proud of our fully automated mandibular nerve tracing functionality with its high clinical relevance for dental implant-based patient rehabilitations.”

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