Surround Medical Systems Announces FDA 510 (k) Pre-Market Clearance for PORTRAY ™ Dental Imaging System | State
MORRISVILLE, North Carolina, August 10, 2021 / PRNewswire / – Surround Medical Systems, Inc. (the “Company”) today announced that the United States Food and Drug Administration (the “FDA”) has granted 510 (k ) for the Company’s patented PORTRAY.™ dental imaging system. 510 (k) pre-market authorization allows commercial sale and use of the PORTRAY™ system as a 2D diagnostic tool and enables 3D tomosynthetic and 2D synthetic imaging as adjunct tools for the production of diagnostic dental x-rays of teeth, jaw and other oral structures. REPRESENT™ is considered the first dental system with FDA 510 (k) pre-market authorization for intraoral use by dentists that features tomosynthetic, or “3D Tomo” imaging.
For more than five decades, intraoral 2D imaging has been the typical x-ray method used by dentists to detect cavities (cavities). Compared to these traditional X-ray systems, the PORTRAY™ The system gives dentists the ability to see tooth decay in its early stages, allows them to visually separate contacts (the teeth that are touching each other), and examine the entire tooth volume, revealing fractures and conditions that were previously invisible or obscured.
The portrait™ The system occupies a comparable footprint and uses the same procedural techniques as 2D machines currently installed in dental practices. The portrait™ The 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 were not previously commercially available.
THE COMPANY PORTRAIT™ system is derived from technological discoveries made in University of North Carolina at Chapel Hill (“A CThere, work advancing x-ray sources incorporating carbon nanotube technologies by the Department of Physics and Astronomy was combined with dental imaging expertise from the Adams School of Dentistry to develop the stationary intraoral tomographic system (“sIOT”) which was the prototype of PORTRAY™ system, which has now received pre-market clearance from the FDA.
The Company expects the PORTRAY™ system will be available for dental offices in the fourth quarter of 2021. The PORTRAY™ system will be assembled and distributed from the Company’s facilities in Morrisville, North Carolina
Dr. Alec parker, Executive Director of the North Carolina Dental Society, said “North Carolina dentists are constantly on the lookout for technologies to improve their diagnostic and clinical skills. Recently, several dentists had the opportunity to see the diagnostic benefits of Tomo 3D images offered by PORTRAY™ system. These dentists consider this new product to be a real breakthrough in clinical diagnosis. The North Carolina Dental Society is an investor in the Society.
David LaVance, the president and CEO of the company, said: “Dentists have been waiting for a major improvement in intraoral dental imaging for more than two decades.™ The system provides dentists with an intraoral 3D dental imaging system that will enable dentists to provide a higher level of patient care by detecting cavities and fractures that would otherwise go undetected by imaging systems. current 2D intraoral dental. The portrait™ system has the potential to dramatically change and improve dental techniques and provide patients with better outcomes and health. “
About Surround Medical Systems, Inc.
Surround Medical Systems, Inc., is a privately held company headquartered in Morrisville, NC. The Company holds the exclusive worldwide rights to develop and commercialize medical and dental systems using carbon nanotube-based X-ray technologies discovered and patented by the University of North Carolina at Chapel Hill. The first product of the company is the PORTRAY™ Dental imaging system with 3D intraoral tomosynthesis. To learn more about the Company, please visit our website at www.surroundmedical.com.
Statements regarding the Company’s future expectations and all other statements contained in this press release other than historical facts are forward-looking statements. Such statements are subject to certain risks, trends and uncertainties which could cause actual results to differ materially from expected results. These risks, trends and uncertainties include economic conditions both in general and within industries in which the company may participate; competition within industries chosen by the Company, including competition from much larger competitors; technological advances; available capital; regulatory approval; and the failure of the Company to successfully develop or acquire products and establish new business relationships. Since these statements involve risks and uncertainties and are subject to change at any time, the actual results of the Company could differ materially from the expected results.
President and CEO
Surround Medical Systems, Inc.
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