DEXIS Receives FDA Clearance for DTX Studio Clinic

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DEXIS, a provider of digital imaging solutions for dentistry, has announced that its latest software offering, DTX Studio Clinic, has received FDA 510(k) clearance for artificial intelligence (AI) findings on 2D intraoral x-ray images. This makes it the first imaging solution to provide six types of pathological dental findings on periapical and bitewing intraoral radiographs and is fully integrated into on-premise imaging software.

New AI Capabilities 

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. With this new AI capability, clinicians can reportedly screen dental radiographs and annotate suspected areas of interest, supporting them in making informed decisions. These clinical conditions include caries, discrepancy at margin, root canal defects, periapical radiolucency, bone loss, and calculus.

According to Amir Aghdaei, CEO of Envista, “DEXIS is empowering practices to embrace digital dentistry for improved efficiencies and predictable patient outcomes. 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.”

DEXIS’ Other FDA Clearances 

In addition to this recent clearance, DEXIS has received several others over the past few years for its AI-powered functionalities. These include FDA clearance for its AI-driven 3D virtual tooth setup algorithm in 2017, automatic tooth position identification and automated sorting of full-mouth x-ray series in 2020, and fully automated mandibular nerve tracing on CBCT scans in 2022.

According to DEXIS, the integration of AI technology into dental imaging software is a promising development for dental professionals, as it can support more accurate and efficient diagnoses while also improving patient outcomes. With DEXIS’ latest clearance, clinicians can present patients with a more comprehensive view of their diagnosis and treatment plan, says the company, building patient understanding and trust while also driving practice efficiencies.

Click here for more information on the DTX Studio Clinic by DEXIS.