VELMENI Gets FDA 510(k) Clearance for 3D Dental Imaging Software

VELMENI has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for VELMENI for DENTISTS 3D, announced in a press release. The software is designed to assist qualified dental professionals in reviewing and analyzing CBCT scans.

VELMENI for DENTISTS 3D includes AI assisted anatomical segmentation, visualization, measurements, panoramic reconstruction, and workflow support. It can help identify and segment structures such as the maxilla, mandible, mandibular canal, teeth, maxillary sinuses, temporomandibular joints, and airway structures.

The software also generates reconstructed panoramic and cross sectional views from CBCT datasets. Other features include 3D visualization, STL export for models, structured reporting, and connections to clinical documentation workflows.

VELMENI said the product is intended to assist dental professionals and does not replace a complete clinical examination, professional judgment, patient history, or patient assessment. Final diagnoses and treatment plans remain the responsibility of the treating dental professional.