A 3D intraoral tomosynthesis imaging device named PORTRAYTM from Surround Medical Systems, Inc. has just received 510(K) clearance from the U.S. Food and Drug Administration (FDA). It is based on the technologies originally developed and patented by researchers from the Department of Physics and Astronomy and the Department of Diagnostic Sciences Section of Oral and Maxillofacial Radiology from the Adams School of Dentistry (ASoD) at University of North Carolina at Chapel Hill (UNC) and licensed to the Research Triangle Park based startup.
The 3D intraoral imaging device has been shown to improve the detection of dentoalveolar diseases without increasing the radiation to the patient or the imaging time comparing to 2D intraoral radiography. It is enabled by a novel carbon nanotube (CNT) x-ray source array also invented at UNC.
Above image is of a sample of the software that comes with device allowing images to be stacked via an algorithm which also can connect with existing patient and practice management systems
The UNC research that led to this new FDA clearance was partially funded by the National Institute of Dental and Craniofacial Research (NIDCR) through a SBIR grant, from The North Carolina Translational and Clinical Sciences Institute (NC TraCS), and Xintek.
A large team of faculty, staff, resident, and student at UNC contributed to this project. The partial list consists of Otto Zhou, Jianping Lu, Christina Inscoe, Jing Shan, and Gongting Wu at Physics; Andrew Tucker, Pavel Chtcheprov and Conner Puett at the Department of Biomedical Engineering; and Enrique Platin, Andre Mol, Lars Gaalaas, Angela Broome, Sally Mauriello, Robert Hilton, Brandon Johnson, Colin LaPrade and Lisa Perrone at the ASoD.
link to Surround Medical Systems website High Resolution X-ray | 3D Intraoral System | Surround Medical
An article featured on Innovate Carolina FDA clears new 3D dental X-ray device based on UNC research | UNC Innovation & Entrepreneurship | Innovate Carolina
Press Release from Surround Medical Systems: SURROUND MEDICAL SYSTEMS ANNOUNCES FDA 510(k) PRE-MARKET CLEARANCE of the PORTRAY™ DENTAL IMAGING SYSTEM | Newswire