Envista Obtains 510(k) FDA Clearance For AI Mandibular Nerve Tracing

(RTTNews) - Envista Holdings Corp. (NVST) said that it has received the 510(k) Food and Drug Administration clearance for 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, the company said.

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, the company said.

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.