VELMENI Receives FDA Clearance for AI-Powered 3D Dental Imaging Software
By Dr. Andrea Joy Smith
Photos Courtesy of VELMENI
VELMENI has received U.S. Food and Drug Administration 510(k) clearance for its artificial intelligence-powered cone-beam computed tomography dental imaging software.
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SUNNYVALE, Calif., July 25, 2026, (DrAndreaJoySmith.com) -- Dental AI company VELMENIannounced it has received 510(k) clearance from the U.S. Food and Drug Administration for VELMENI for DENTISTS (V4D) 3D, an artificial intelligence-powered software platform designed to assist dental professionals in reviewing and analyzing cone-beam computed tomography (CBCT) scans.
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The software uses artificial intelligence to assist with anatomical segmentation, image visualization, measurements, panoramic reconstruction, and workflow support for CBCT imaging.
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The platform is intended for use by general dentists, oral and maxillofacial radiologists, oral surgeons, orthodontists, prosthodontists, endodontists, dental service organizations, and imaging centers.
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“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,” said Mini Suri, Chief Executive Officer and co-founder of VELMENI.
According to the company, the software identifies and segments anatomical structures including the maxilla, mandible, mandibular canal, teeth, maxillary sinuses, temporomandibular joints, and airway structures. It also generates reconstructed panoramic and cross-sectional images, provides measurement tools, and allows users to export three-dimensional STL files for patient education and collaboration.
The software also integrates structured reporting, clinical documentation, and workflow management into its broader VELMENI ONE platform, which combines artificial intelligence-assisted two-dimensional dental imaging, three-dimensional CBCT analysis, voice-enabled clinical documentation, reporting tools, insurance claims automation, and practice management integrations.
“As an oral and maxillofacial radiologist, I have seen how responsibly developed artificial intelligence can improve consistency and efficiency in dental imaging review while supporting clinical decision-making,” said Dr. Dale Miles, oral and maxillofacial radiologist and CBCT advisor to VELMENI.
“VELMENI brings together three important AI-native workflows—voice, two-dimensional imaging, and three-dimensional imaging—within one connected platform. The system is intuitive, and the reduction in repetitive workload can be immediate,” said Dr. Nodesh Shyamsunder, an oral and maxillofacial prosthodontist.
VELMENI states that the software is intended to assist qualified dental professionals and is not a substitute for clinical examination, professional judgment, patient history, or treatment planning.
VELMENI develops artificial intelligence-powered software designed to support clinical and administrative workflows for dental practices, specialists, dental service organizations, and imaging centers.
For more information, visit www.velmeni.ai.
Source: VELMENI