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The deal expands Positron’s manufacturing role to that of a contracted components supplier for its PET-CT imaging device ahead of its 510(k) submission.

Katie Hobbins

July 24, 2023

2 Min Read
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fizkes / iStock via Getty Images

Positron Corporation, a molecular imaging medical device company, recently announced it has transferred its original business cooperation agreement with Neusoft Medical Systems to include an innovation agreement with Neusoft’s subsidiary, Intelligent Neuclear Medical (INM). The companies said they’ve entered into the agreement to redefine key functions and responsibilities to improve long-term production.

As part of the agreement, Positron has expanded its role as manufacturer with INM to become the company’s contract components supplier. This classification will register Positron with the FDA as the applicant for its 510(k) Affinity Positron Emission Tomography (PET)-CT Medical Device Clearance submission.

The PET-CT system is a 4D imaging device that collects imaging data for oncology, neurology, and cardiac diagnosis. It includes proprietary respiratory gating technology, a new quantitative analysis tool, and new AI-based image reconstruction technology. The system includes oncologic serial analysis software, cardiac tools, and a coronary artery overlay display.

“Going forward Positron will adhere to all FDA requirements, quality systems regulations, and import regulations,” according to the press release announcing the agreement. “Through its role as manufacturer, Positron will be able to observe and comply with FDA requirements and perform future device and procedural reviews more efficiently.”

Additionally, Positron said the new agreement structure with Neusoft and INM will enable greater communication between companies and create more opportunities for direct input throughout the division, fast tracking future deliverables.

“We are pleased with the new organization within Neusoft; it is a testament to their focus on R&D and advancing nuclear products,” said Adel Abdullah, president of Positron, in the release. “The formation of this new Intelligent Neuclear Medicine subsidiary combined with Positron taking the lead on manufacturing duties is by design so that both parties can improve the execution and efficiencies required to deliver the best PET-CT products as well as our ability to scale. We are excited to bring to market our Affinity PET-CT 4D and to become a key part of an expanding nuclear cardiology imaging market and the vast oncology imaging segment.”

About the Author(s)

Katie Hobbins

Managing Editor, MD+DI

Katie Hobbins is managing editor for MD+DI and joined the team in July 2022. She boasts multiple previous editorial roles in print and multimedia medical journalism, including dermatology, medical aesthetics, and pediatric medicine. She graduated from Cleveland State University in 2018 with a bachelor's degree in journalism and promotional communications. She enjoys yoga, hand embroidery, and anything DIY. You can reach her at [email protected].

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