Dental AI company Velmeni has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Velmeni for Dentists (V4D) 3D software.
The cleared system applies AI to three-dimensional cone-beam computed tomography (CBCT) scans, expanding Velmeni’s portfolio of dental imaging tools.
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The software aims to aid qualified dental professionals in reviewing and analysing CBCT scans by providing AI-assisted anatomical segmentation, 3D visualisation, measurement capabilities, and image reconstruction.
It is intended for use by endodontists, dental service organisations, general dentists, imaging centres, orthodontists, oral surgeons, and prosthodontists.
V4D 3D aims to help clinicians interpret complex CBCT data by delivering tools such as intelligent segmentation of anatomical structures and automated panoramic and cross-sectional views.
The software also provides clinically relevant measurements and high-resolution multidimensional visualisations.
It also supports standard tessellation language (STL) file export for creating 3D models, which can be used for educational purposes and collaboration.
Integrated reporting and workflow features are included to assist with patient documentation and communication.
Velmeni states that the product is meant to support qualified dental professionals, rather than serve as a substitute for a full clinical examination, professional judgment, patient history, or direct assessment.
The company indicates that responsibility for final diagnoses, treatment decisions, and patient management remains with the treating dental professional.
Velmeni CEO and co-founder Mini Suri said: “Velmeni’s vision extends beyond isolated AI image interpretation. Our 3D AI helps clinicians review complex CBCT scans more efficiently, supporting confident decisions while streamlining the clinical workflow.”
The newly cleared software becomes part of the Velmeni One platform, which brings together 2D dental X-ray analysis, voice-enabled periodontal charting, automated reporting, claims automation, and workflow integrations.
