DEXIS Announces FDA 510(k) Clearance of Pathological Dental Findings AI on 2D Intraoral X-ray Images

DEXIS announces FDA 510(k) Clearance for dental findings AI on 2D intraoral X-ray images. As the next generation of DEXIS software, DTX Studio Clinic now offers the first and only imaging solution with six types of pathological dental findings on periapical and bitewing intraoral radiograph images and is fully integrated into on-premise imaging software. DTX Studio Clinic is an imaging acquisition, diagnosis, and treatment planning software and is part of the DTX Studio suite of products used by over 10,000 dental offices.

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DTX Studio Clinic screens dental radiographs and annotates suspected areas of interest, supporting the clinician in making informed decisions. These clinical conditions include six types of pathological dental findings: caries, discrepancy at margin, root canal defects, periapical radiolucency, bone loss and calculus. With DTX Studio Clinic, clinicians can present patients with a more comprehensive view of the diagnosis and treatment plan, building patient understanding and trust while also driving practice efficiencies.

This clearance further complements a series of enhanced AI-powered functionalities 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. In 2022, the FDA cleared the fully automated mandibular nerve tracing on CBCT scans. These continual enhancements and innovations have earned DTX Studio Clinic back-to-back Cellerant Best of Class Technology Awards, as well as high praise from doctors.

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“DEXIS is empowering practices to embrace digital dentistry for improved efficiencies and predictable patient outcomes,” says Amir Aghdaei, CEO Envista. “With our newest release of DTX Studio Clinic, featuring enhanced built-in AI features like the pathological dental findings, practices now have an enhanced solution for their digital workflow — from diagnosis to treatment planning to delivery of care.”

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