Surround Medical Systems Gains FDA Clearance for 3D Dental Imaging System

A new dental imaging system that can help dentists see tooth decay earlier and in greater detail has received regulatory clearance and is expected to be commercially available by the end of the year from its developer, Surround Medical Systems of Morrisville.

The patented Portray system was granted 510(k) pre-market clearance by the U.S. Food and Drug Administration, allowing its commercial sale and use.

"Dentists have been waiting for a major improvement to intraoral dental imaging for more than 50 years,” said David LaVance, president and chief executive officer of Surround Medical Systems. “The Portray system provides dentists with an intraoral 3D dental imaging system that will allow the dentists to provide a higher level of care for patients by detecting cavities and fractures that would otherwise go undetected by current 2D intraoral dental imaging systems. The Portray system has the potential to substantially change and improve dental techniques and provide patients better outcomes and improved health."

The Portray system is believed to be the first dental system with a 510(k) pre-market clearance for intraoral use by dentists that features tomosynthetic, or "3D Tomo," imaging, an improvement over the 2D imaging that has been the typical X-ray method of detecting cavities for the last five decades.

The Portray system enables dentists to see tooth decay in its earlier stages, visually separate contacts (teeth that touch), and examine the entire volume of the tooth, revealing fractures and conditions that were previously invisible or obscured.

The FDA clearance allows the Portray system to be used as a 2D diagnostic tool and allows 3D tomosynthetic and 2D synthetic imaging as adjunctive tools for producing diagnostic dental radiographs of teeth, jaw and other oral structures.

The Portray system deploys multiple X-ray beams to generate imaging "slices" that are reconstructed using the company's proprietary software to create 3D tomosynthetic and 2D synthetic images that previously have not been commercially available.

The system is derived from technology discoveries made at the University of North Carolina at Chapel Hill more than a decade ago. Work to advance X-ray sources featuring carbon nanotube technologies was done by UNC’s Department of Physics and Astronomy. Dental imaging expertise in UNC’s Adams School of Dentistry helped develop the stationary intraoral tomographic system that was the prototype for the Portray system.

"North Carolina dentists are constantly on the lookout for technology to enhance their diagnostic and clinical skills,” said Alec Parker, DMD, executive director of the North Carolina Dental Society, an investor in Surround Medical Systems. “Recently, several dentists had an opportunity to see the diagnostic advantages of 3D Tomo images offered by the Portray system. These dentists consider this new product to be a real breakthrough for clinical diagnosis."

The Portray system will be assembled at the company's facility in Morrisville and distributed to dental offices beginning this quarter.