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VELMENI Secures FDA Approval for AI-Driven 3D Dental Imaging

Sunnyvale-based dental AI firm VELMENI has received FDA 510(k) clearance for its V4D 3D software, a tool designed to automate the segmentation and analysis of cone-beam computed tomography scans, marking a significant expansion of the company’s diagnostic capabilities for oral surgeons, orthodontists, and general practitioners.

Bio & NewsJuly 24, 2026661 reads0

The new software integrates directly into the broader VELMENI ONE platform, which combines 2D X-ray analysis, voice-enabled documentation, and now, complex 3D volumetric imaging. By automating the identification of anatomical structures—including the mandible, maxillary sinuses, and airway passages—the system aims to reduce the manual labor required for treatment planning and surgical preparation. Clinicians can use the platform to generate panoramic reconstructions and export STL files, facilitating better patient communication and specialist collaboration.

CEO Mini Suri emphasized that the technology is intended to assist, rather than replace, clinical expertise. The platform functions as a support layer for professionals to navigate datasets more efficiently, ensuring that final diagnostic decisions remain firmly in the hands of the treating practitioner. According to Dr. Dale Miles, an oral and maxillofacial radiologist and advisor to the firm, the integration of AI into these imaging workflows provides a necessary boost to consistency and clinical decision-making speed across dental practices.

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