Positron Strikes Manufacturing Deal with Intelligent Neuclear Medical
24 Jul 2023
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.”
“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.”
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