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. Positron will continue to advance the technology through its manufacturing and R&D venture with Neusoft Medical Systems. Positron's PET-CT also allows the Company to fully service and meet the demands of the vast oncology diagnostics marketplace.
#Affinity clinic full
Positron will soon offer a state-of-the-art PET-CT molecular imaging device that will enable nuclear cardiologists to utilize the full capabilities of molecular imaging and nuclear medicine. Positron's dedicated PET system, Attrius(R) PET, and unique market position are substantial advantages in facilitating the adoption of cardiac PET and the growth of the nuclear imaging market. Positron's innovative PET technology, clinical services and practice solutions enables healthcare providers to accurately diagnose coronary artery disease and improve patient outcomes while practicing cost effective medicine. Positron specializes in the field of cardiac Positron Emission Tomography (PET) imaging - the gold standard in cardiac diagnostics. Positron Corporation is a molecular imaging device company that offers a state-of-the-art PET imaging system and clinical services to nuclear medicine healthcare providers throughout North America. We look forward to meeting the demands of an expanding nuclear imaging device market with our Affinity PET-CT 4D providing an optimal solution." 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. Positron expects completion of its clinical study and FDA Certification within the next 60 days.Īdel 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.
#Affinity clinic trial
During the clinical trial period, the Company will also submit its new device 510k to 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.
Clinical studies are most often conducted to support a PMA (Pre-Market Approval) as required in the submission of a 510k with the FDA.
The clinical study will be registered in accordance with the requirements of the International Committee of Medical Journal Editors.
Under FDA regulations, an IRB is an appropriately constituted group formally designated to review and monitor biomedical research involving human subjects.Īcceptance 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. All procedures and participants for the clinical study have been evaluated and approved as required by an independent Institutional Review Board (IRB).
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