Velmeni Receives FDA Clearance for AI-Powered 3D CBCT Dental Imaging Software
The U.S. Food and Drug Administration (FDA) has granted VELMENI 510(k) clearance for its new AI-powered 3D CBCT dental imaging software, VELMENI for DENTISTS (V4D) 3D.
SUNNYVALE, California – VELMENI announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for VELMENI for DENTISTS (V4D) 3D, its new artificial intelligence-powered software for Cone Beam Computed Tomography (CBCT) dental imaging.
The clearance expands VELMENI's AI offerings into three-dimensional imaging. The software is designed to assist dental professionals in analyzing CBCT scans by using AI for the segmentation, visualization, measurement, and reconstruction of anatomical structures, aiming to streamline workflows for dental practices, specialists, and imaging centers.
VELMENI for DENTISTS 3D automatically identifies and segments anatomical structures in the oral and maxillofacial region, such as the jawbones, sinuses, and teeth. The software also automatically generates panoramic and cross-sectional views from CBCT data. It provides measurement tools and 3D visualization for treatment planning and can export STL files for creating 3D models for patient education and collaboration.
"VELMENI's 3D AI helps clinicians review complex CBCT scans more efficiently, supporting confident decisions while streamlining the clinical workflow," said Mini Suri, CEO and Co-Founder of VELMENI. The VELMENI ONE platform integrates 2D X-ray analysis, 3D CBCT imaging, and voice-enabled periodontal charting and clinical documentation.