August 10, 2021 (Newswire.com) –
Encompass Medical Programs, Inc. (the “Firm”) introduced as we speak that the US Meals and Drug Administration (the “FDA”) has granted 510(ok) pre-market clearance for the Firm’s patented PORTRAYTM dental imaging system. The 510(ok) pre-market clearance permits the business sale and use of the PORTRAYTM system as a 2D diagnostic instrument and permits 3D tomosynthetic and 2D artificial imaging as adjunctive instruments for producing diagnostic dental radiographs of enamel, jaw, and different oral buildings. PORTRAYTM is believed to be the primary dental system with a 510(ok) pre-market clearance from the FDA for intraoral use by dentists that options tomosynthetic, or “3D Tomo”, imaging.
For greater than 5 a long time, intraoral 2D imaging has been the standard X-ray technique that dentists have used to detect caries (cavities). As in comparison with these conventional X-ray techniques, the PORTRAYTM system provides dentists the power to see tooth decay in its earlier levels, permits them to visually separate contacts (enamel that contact) and look at the whole quantity of the tooth, revealing fractures and situations that have been beforehand invisible or obscured.
The PORTRAYTM system occupies a comparable footprint and makes use of the identical procedural strategies as 2D machines at present put in in dental workplaces. The PORTRAYTM system deploys a number of X-ray beams to generate imaging “slices” which are reconstructed utilizing the Firm’s proprietary software program to create 3D tomosynthetic and 2D artificial pictures that beforehand haven’t been commercially obtainable.
The Firm’s PORTRAYTM system is derived from expertise discoveries made on the College of North Carolina at Chapel Hill (“UNC”). There, the work advancing X-ray sources that includes carbon nanotube applied sciences by the Division of Physics and Astronomy was mixed with the dental imaging experience of the Adams College of Dentistry to develop the stationary intraoral tomographic system (“sIOT”) that was the prototype for the PORTRAYTM system, which has now obtained pre-market clearance from the FDA.
The Firm expects the PORTRAYTM system to be obtainable to dental practices within the fourth quarter of 2021. The PORTRAYTM system will likely be assembled at and distributed from the Firm’s facility in Morrisville, N.C.
Dr. Alec Parker, Government Director of the North Carolina Dental Society, acknowledged “North Carolina dentists are always looking out for expertise to boost their diagnostic and scientific expertise. Just lately, a number of dentists had a possibility to see the diagnostic benefits of 3D Tomo pictures supplied by the PORTRAYTM system. These dentists take into account this new product to be an actual breakthrough for scientific prognosis.” The North Carolina Dental Society is an investor within the Firm.
David LaVance, the President and Chief Government Workplace of the Firm, acknowledged, “Dentists have been ready for a serious enchancment to intraoral dental imaging for greater than twenty years. The PORTRAYTM system supplies dentists with an intraoral 3D dental imaging system that may permit the dentists to offer the next stage of look after sufferers by detecting cavities and fractures that may in any other case go undetected by present 2D intraoral dental imaging techniques. The PORTRAYTM system has the potential to considerably change and enhance dental strategies and supply sufferers higher outcomes and improved well being.”
About Encompass Medical Programs, Inc.
Encompass Medical Programs, Inc., is a privately-held company headquartered in Morrisville, NC. The Firm has the unique worldwide rights to develop and market medical and dental techniques using carbon nanotube-based X-ray applied sciences found at and patented by the College of North Carolina at Chapel Hill. The Firm’s first product is the PORTRAYTM Dental Imaging System that includes 3D intraoral tomosynthesis. To be taught extra in regards to the Firm, please go to our web site at www.surroundmedical.com.
Statements in regards to the Firm’s future expectations and all different statements on this press launch aside from historic info are forward-looking statements. Such statements are topic to sure dangers, tendencies and uncertainties that might trigger precise outcomes to vary materially from anticipated outcomes. Amongst these dangers, tendencies and uncertainties are financial situations each typically and throughout the industries by which the corporate could take part; competitors throughout the Firm’s chosen industries, together with competitors from a lot bigger rivals; technological advances; obtainable capital; regulatory approval; and failure by the Firm to efficiently develop or purchase merchandise and type new enterprise relationships. Since these statements contain dangers and uncertainties and are topic to vary at any time, the Firm’s precise outcomes may differ materially from anticipated outcomes.
President and Chief Government Officer
Encompass Medical Programs, Inc.
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