March 21, 2023 — Positron Corporation, a molecular imaging device company that offers PET imaging systems and clinical services, is pleased to announce that it has executed a Clinical Study/Research Agreement with Ochsner Clinic Foundation and Dr. Robert Bober, Director of Molecular Imaging and Nuclear Cardiology at Ochsner Health, for the clinical study of its new PET-CT imaging device, the Affinity PET-CT 4D.
All procedures and participants for the clinical study have been evaluated and approved as required by an independent Institutional Review Board (IRB). Under FDA regulations, an IRB is an appropriately constituted group formally designated to review and monitor biomedical research involving human subjects.
Acceptance of the clinical study by the IRB allows Positron to obtain an Investigational Device Exemption (IDE) which is required to collect safety and efficacy data for Positron’s new PET-CT device. The clinical study will be registered in accordance with the requirements of the International Committee of Medical Journal Editors. Clinical studies are most often conducted to support a PMA (Pre-Market Approval) as required in the submission of a 510k with the FDA.
Positron has met all criteria to immediately begin the installation process and phantom testing in preparation for patient scans that will begin upon receiving an IDE as required for human studies. During the clinical trial period, the Company will also submit its new device 510k to the FDA. Positron expects completion of its clinical study and FDA Certification within the next 60 days.
Adel Abdullah, President of Positron, stated, “This study is key in the commercialization of the Affinity PET-CT 4D and we are very pleased to be working with such esteemed industry leaders in Ochsner Clinic Foundation and Dr. Bober. We are conducting this rigorous clinical study for the validation of our Affinity PET-CT 4D’s to demonstrate its superior capabilities and robust utilization across cardiology and oncology segments of nuclear molecular imaging. We look forward to meeting the demands of an expanding nuclear imaging device market with our Affinity PET-CT 4D providing an optimal solution.”
For more information: www.positron.com