This 510(k) also will facilitate future FDA clearances, including for the Company’s Affinity PET-CT 4D 64 slice system

June 13, 2024 — Positron Corporation, a leading molecular imaging medical device company offering PET and PET-CT (Positron Emission Tomography/Computed Tomography) imaging systems and clinical support services, announced it has entered an agreement to acquire the FDA 510(k) for the NeuSight PET-CT from its cooperative partner Neusoft Medical Systems’ subsidiary, Shenyang Intelligent Neuclear Medical Technology Co.  

A 510(k) is a premarket submission made to the FDA (U.S. Food and Drug Administration) to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device. Positron’s ownership of the existing 510(k) and FDA clearance will enable the marketing and sale of the NeuSight PET-CT 64 slice imaging system. This 510(k) also will facilitate future FDA clearances, including for the Company’s Affinity PET-CT 4D 64 slice system. This agreement allows Positron to immediately market and sell the NeuSight PET-CT, with plans to introduce Positron’s Affinity PET-CT 4D pending acceptance of an amended 510(k) submission.  

Adel Abdullah, President of Positron stated, “Gaining the 510(k) is a significant milestone in Positron’s mission to offer outstanding PET-CT technology and solutions to healthcare practices and hospitals serving both the cardiac and oncology segments of molecular imaging. Our PET imaging product line will now feature PET-CT which will expand access for physicians and practitioners seeking to utilize the full capabilities of the PET modality in nuclear cardiology and oncology.  PET-CT imaging remains at the forefront of oncology studies and has become vital to the future of nuclear cardiology. With the addition of PET-CT, Positron has a range of core products that blend cutting edge technology with strong economics, appealing to most nuclear imaging specialist and practices.”

Mr. Abdullah further added, “We appreciate the full support of Neusoft Medical Systems whose unwavering support and expertise in imaging technologies and extensive R&D continues to enhance our current and future capabilities. I am confident in Positron’s important role in advancing the PET modality and our commitment to delivering the best value in the industry.”

For more information: www.positron.com


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