Positron Corporation Enters Agreement to Acquire FDA 510(k) for NeuSight PET-CT
Positron (OTC: POSC) has entered an agreement to acquire the FDA 510(k) clearance for the NeuSight PET-CT from Neusoft Medical Systems' subsidiary. This acquisition enables Positron to immediately market and sell the NeuSight PET-CT 64 slice imaging system and facilitates future FDA clearances for their Affinity PET-CT 4D 64 slice system. Adel Abdullah, President of Positron, emphasized that this milestone will significantly enhance their product line, which is vital for both oncology and nuclear cardiology. Positron aims to offer advanced PET-CT technology to healthcare practices, supported by Neusoft's extensive R&D expertise.
- Positron acquires FDA 510(k) clearance for NeuSight PET-CT, allowing immediate sales.
- Facilitates future FDA clearances for Affinity PET-CT 4D 64 slice system.
- Expands product line to include advanced PET-CT technology, essential for oncology and nuclear cardiology.
- Enhanced market position and competitiveness in the molecular imaging sector.
- Supported by Neusoft Medical Systems' expertise and R&D capabilities.
- The acquisition of FDA 510(k) clearance may involve significant costs.
- Potential risks related to market acceptance and competition for the newly acquired PET-CT system.
- Delays in obtaining future FDA clearances for other products could impact sales and revenue.
Niagara Falls, NY, June 12, 2024 (GLOBE NEWSWIRE) -- Positron Corporation (“Positron” or the “Company”) (OTC: POSC), a leading molecular imaging medical device company offering PET and PET-CT (Positron Emission Tomography/Computed Tomography) imaging systems and clinical support services, is pleased to announce 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.”
About Positron Corporation
Positron Corporation is a medical technology company that co-develops, manufactures, and sells state-of-the-art PET and PET-CT imaging systems and clinical services to nuclear medicine healthcare providers throughout North America.
Positron specializes in the field of cardiac Positron Emission Tomography (PET) imaging, the gold standard in cardiac diagnostics. Positron’s innovative PET/PET-CT technologies, clinical services and practice solutions enables healthcare providers to accurately diagnose coronary artery disease and improve patient outcomes while practicing cost effective medicine.
Positron's Attrius® PET and NeuSight PET-CT imaging systems and distinct market position are substantial advantages unique to Positron that will facilitate the adoption of cardiac PET and the growth of the nuclear imaging market. Positron will soon offer a state-of-the-art PET-CT 4D molecular imaging device in the Affinity PET-CT 4D 64-Slice. Positron’s PET-CT(s) will enable nuclear cardiologists to utilize the full capabilities of molecular imaging and nuclear medicine. Positron’s PET-CT systems will also enable the Company to fully service and meet the demands of the vast oncology imaging segment of nuclear medicine.
Positron is committed to expanding the cardiac and oncology PET modality by delivering the best technology and value to imaging specialists and will continue to advance its technology through its co-developer, supplier, and R&D venture with Shenyang Intelligent Neuclear Technology Co. a subsidiary of Neusoft Medical Systems.
About Neusoft Medical Systems Co., Ltd.
Neusoft Medical Systems is a leading global clinical diagnosis and treatment solution provider, headquartered in China. Neusoft Medical Systems is constantly innovating its portfolio of medical imaging diagnosis and clinical solutions in CT, MRI, DSA, XR, PET/CT, RT, US and IVD. Neusoft Medical Systems also is developing MDaaS (Medical Devices & Data as a Service), a strategic product line built using the Internet, big data, artificial intelligence, combined with other technologies improving medical institutions' ability to diagnose and treat patients, achieving operational excellence. Innovation is always the driving force of Neusoft Medical Systems. Neusoft Medical Systems is collaborating with global scientists and medical institutions dedicated to advancing the technology of medical imaging solutions. Together with 45,000 installations in more than 110 countries, Neusoft Medical Systems provides advanced, high-quality medical imaging solutions to patients around the world. Neusoft Medical Systems is dedicated to being an excellent value innovator of global healthcare services. Through innovation and excellent operations, Neusoft Medical Systems is advancing healthcare products across a wide range of medical solutions and services to enhance global healthcare for all.
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. Words such as "anticipate," "if," "believe," "plan," "estimate," "expect," "intend," "may," "could," "should," "will," and similar expressions are forward-looking statements and involve risks, uncertainties and contingencies, many of which are beyond our control, which may cause actual results, performance, or achievements to differ materially from anticipated results, performance, or achievements. 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 even if new information becomes available in the future.
FOR FURTHER INFORMATION, please visit the company’s website at www.positron.com, or contact: investor@positron.com
FAQ
What is the significance of Positron acquiring the FDA 510(k) for NeuSight PET-CT?
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