Positron Corporation Retains FDA Consulting Firm in Preparation for 510K New Device Application

Rhea-AI Summary

Positron Corporation (OTC: POSC) announced its partnership with Medical Device Academy (MDA) to assist in the 510K submission for its new PET/CT device to the FDA. The company aims to file the application within 60 days, seeking approval within 100 days of filing. President Adel Abdullah highlighted MDA's expertise as crucial for the application process. This advancement is part of Positron's strategy to enhance cardiac and oncology diagnostics, positioning its innovative PET technology to meet market demand.

Positive

• Engagement of Medical Device Academy for FDA 510K submission enhances credibility.
• Anticipation of FDA approval within 100 days of filing bolsters investor confidence.
• New PET/CT device aims to improve diagnostic capabilities in cardiac and oncology fields.

Negative

• None.

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 statements, which may constitute "forward-looking statements" within the meaning of the Securities Act of 1933 and the Securities Exchange Act of 1934, as amended by the Private Securities Litigation Reform Act of 1995. Those statements include statements regarding the intent, belief or current expectations of Positron Corporation, and members of its management as well as the assumptions on which such statements are based. Prospective investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, and that actual results may differ materially from those contemplated by such forward-looking statements. The Company undertakes no obligation to update or revise forward-looking statements to reflect changed assumptions, the occurrence of unanticipated events or changes to future operating results.

FOR FURTHER INFORMATION, please visit the company’s website at www.positron.com, or contact: 


Investor Relations Contact:
Skyline Corporate Communications Group, LLC
Lisa Gray, Senior Account Manager
One Rockefeller Plaza, 11th Floor
New York, NY 10020
Office: (646) 893-5835
Email: lisa@skylineccg.com

FAQ

What is Positron Corporation's latest announcement regarding FDA submission?

Positron Corporation has retained Medical Device Academy to assist with its 510K submission for a new PET/CT device to the FDA.

When does Positron plan to file its 510K application with the FDA?

Positron plans to file its 510K application within 60 days of the announcement.

What is the expected timeline for FDA approval of Positron's PET/CT device?

Positron anticipates receiving FDA approval within 100 days from the initial filing date.

How does Positron's new PET/CT device impact cardiac and oncology diagnostics?

The new PET/CT device aims to enhance diagnostic capabilities for cardiac patients and oncology customers.