Pearl, a Los Angeles-based artificial intelligence dental company, announced that its Second Opinion® 3D platform has received 510(k) clearance from the U.S. Food and Drug Administration (FDA).
According to the company, this certification makes Pearl the first and only AI company with FDA-cleared 2D and 3D dental radiography analysis solutions.
The new platform approval expands Pearl’s existing AI technology to cone beam computed tomography (CBCT) images.
According to the company, Second Opinion® 3D automatically identifies key anatomical structures in 3D images, including dentition, maxilla, mandible, alveolar canals and mental foramina, maxillary sinuses, nasal cavity and airway.
“Pearl is committed to providing the most advanced and clinically reliable AI solutions to the dental industry,” said Pearl founder and CEO Ophir Tanz.
Being the first company to receive FDA clearance for 2D and 3D radiology analysis is a significant achievement not only for us, but for the dental industry as a whole.”
The company noted that Second Opinion® 3D is designed to help dental professionals review CBCT scans more quickly, accurately, and clearly.
The AI visualizations generated by the system can be used to support diagnosis and treatment planning in multiple specialties, including implant dentistry, orthodontics, oral surgery, and airway management.
Prior to receiving FDA clearance, Second Opinion® 3D underwent performance testing. According to Pearl, the software performed well in segmentation accuracy of all target anatomical structures, with Dice similarity coefficients exceeding clinically accepted standards.
Pearl’s original Second Opinion® platform has long been FDA-cleared for the identification of pathology in 2D dental radiology images.
With the addition of 3D capabilities, Pearl now has the industry’s only FDA-cleared AI platform for both major dental imaging modalities.
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