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Positron Corporation Retains FDA Consulting Firm in Preparation for 510K New Device Application
Positron Corporation Retains FDA Consulting Firm in Preparation for 510K New Device Application.
About this update from Positron Corp.
[{"type":"text","content":"\n Niagara Falls, NY , Feb. 17, 2022 (GLOBE NEWSWIRE) -- Positron Corporation (“Positron” or the “Company”) (OTC: POSC), a nuclear medicine PET imaging device systems and clinical services company, is pleased to announce today that the Company has retained Medical Device Academy ”MDA”) as its consultant for the Company’s new PET/CT device 510K submission with the Food and Drug Administration (“FDA”).  Positron will be applying for new device approval to market and sell its PET/CT device in the United States. The Company plans to file its 510K application within 60 days and anticipates it will receive approval within 100 days from initial filing date.  Adel Abdullah, President of Positron stated: “The seasoned team at MDA come highly recommended for their expertise, analysis and assessment of the processes required for our new application to be successfully cleared by the FDA.  During the past several months we have been preparing our database to accept & present all relevant information and documentation for our 510K application. Hiring a skilled specialist such as MDA is key and the next step for Positron’s business to offer a state-of-the-art PET/CT device delivering the best images for cardiac patients and our future expected oncology customers.” About Positron Corporation About Positron: Positron Corporation is a nuclear medicine PET imaging device company specializing in the field of cardiac Positron Emission Tomography imaging - the gold standard in cardiac diagnostics. Positron’s innovative PET technology, clinical services and practice solutions enables healthcare providers to more accurately diagnose coronary artery disease and improve patient outcomes while practicing cost effective medicine.  Positron's PET only system, market position and approach in facilitating the adoption of cardiac PET are substantial advantages to the growth of the market and Positron. Positron will soon offer a state-of-the-art PET/CT imaging device that will enable nuclear cardiologists to utilize the full power of nuclear imaging. This same PET/CT device allows Positron to address and meet the needs and demand of the vast oncology diagnostics marketplace.      Forward-Looking Statements This press release contains st...