VELMENI has received U.S. Food and Drug Administration (FDA) 510(k) clearance for VELMENI for DENTISTS (V4D) 3D, expanding the company’s dental artificial intelligence portfolio into three-dimensional cone-beam computed tomography (CBCT) imaging.
According to the company, V4D 3D is designed to assist qualified dental professionals in reviewing and analyzing CBCT scans through AI-assisted anatomical segmentation, visualization, measurements, and image reconstruction. The software is intended for use by general dentists, oral and maxillofacial radiologists, oral surgeons, orthodontists, prosthodontists, endodontists, dental service organizations, and imaging centers.
“VELMENI’s vision extends beyond isolated AI image interpretation,” said Mini Suri, CEO and co-founder of VELMENI. “Our 3D AI helps clinicians review complex CBCT scans more efficiently, supporting confident decisions while streamlining the clinical workflow.”
According to the company, the software applies artificial intelligence to assist dental professionals in navigating CBCT datasets and generating visualizations for clinical review. Features include AI-assisted segmentation of anatomical structures such as the maxilla, mandible, mandibular canal, teeth, maxillary sinuses, temporomandibular joints, and airway structures; automated panoramic reconstruction and cross-sectional views; clinically relevant measurements and multi-dimensional visualization; export of STL files for case presentation, specialist collaboration, and dental laboratory communication; and structured reporting integrated with clinical documentation and workflow tools.
The company emphasized that VELMENI for DENTISTS 3D is intended to assist qualified dental professionals and is not a replacement for a complete clinical examination, professional judgment, patient history, or in-person assessment. According to the company, final diagnoses, treatment recommendations, and treatment plans remain the responsibility of the treating dental professional.
“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 Dale Miles, DDS, MS, FRCD(C), oral and maxillofacial radiologist, DoctorConeBeam, 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,” said Nodesh Shyamsunder, oral and maxillofacial prosthodontist. “The system is intuitive, and the reduction in repetitive workload can be immediate.”
According to the company, V4D 3D is part of the VELMENI ONE platform, which combines AI-assisted two-dimensional dental radiograph analysis, AI-powered 3D CBCT imaging and visualization, voice-enabled periodontal charting and clinical documentation, automated CBCT reporting support, dental insurance claims automation, and clinical workflow and practice-management integrations. The company said the platform is designed to connect clinical imaging, documentation, patient communication, and administrative workflows within a single system.
According to the company, VELMENI develops AI-powered technology for dental practices, specialists, dental service organizations, and imaging centers, with products that combine imaging, voice-enabled documentation, structured reporting, and workflow automation.
