Envista receives FDA approval for DTX Studio Clinic feature

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Envista’s newest FDA approval complements other AI-powered features in DTX Studio Clinic

The AI-assisted feature of Envista’s DTX Studio Clinic helps clinicians trace the mandibular nerve, preventing complications during dental implant procedures. (Image: Alex Mit/Shutterstock)
Dental Tribune International

Dental Tribune International

Mon. 11. April 2022


BREA, Calif., US: Envista’s assisted intelligence (AI) mandibular nerve tracing feature in its image acquisition and diagnostic software platform DTX Studio Clinic has recently received 510(k) clearance from the US Food and Drug Administration (FDA). Commenting on the approval, Envista CEO Amir Aghdaei emphasised that this clearance is another important step for the company’s digital strategy of expanding the capabilities of the dental diagnostic software platform DTX Studio Clinic.

To manually trace the mandibular nerve can be time-consuming and sensitive to error. According to the company, the AI-assisted feature of the DTX Studio Clinic supports clinicians in performing this important task. Correct visualisation of the mandibular nerve is of high importance for modern dentistry as it has an impact on the patient’s treatment options and may prevent complications.

In a press release, Aghdaei explained how proud the company is of its fully automated mandibular nerve tracing functionality and its high clinical relevance for dental implant procedures. He said: “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.”

The current FDA clearance is preceded by the approval of Envista’s AI-driven 3D virtual tooth set-up algorithm in 2017 and its automatic tooth position identification and automated sorting of full-mouth radiographic series in 2020.

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