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

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


Related Content

News | Radiology Imaging

November 30, 2023 — Through its leading imaging solutions and commitment to innovation, GE HealthCare remains at the ...

Time November 30, 2023
arrow
News | Contrast Media

November 29, 2023 — Bayer continues to advance its comprehensive Radiology portfolio with progress in the development ...

Time November 29, 2023
arrow
News | RSNA

November 28, 2023 — iCAD, Inc., a global medical technology company developing cancer-detection solutions, will present ...

Time November 28, 2023
arrow
News | RSNA

November 28, 2023 — New research being presented this week at the annual meeting of the Radiological Society of North ...

Time November 28, 2023
arrow
News | Magnetic Resonance Imaging (MRI)

November 27, 2023 — Stronger quadriceps muscles, relative to the hamstrings, may lower the risk of total knee ...

Time November 27, 2023
arrow
News | Quality Assurance (QA)

November 25, 2023 — Mirion announced that it will debut the new Instadose VUE personal dosimeter, from its Dosimetry ...

Time November 25, 2023
arrow
News | PET-CT

November 22, 2023 — Siemens Healthineers announces the Food and Drug Administration (FDA) clearance of the Biograph ...

Time November 22, 2023
arrow
News | Artificial Intelligence

November 21, 2023 — Heuron, a medical AI (artificial intelligence) imaging software solution company, under the ...

Time November 21, 2023
arrow
News | Information Technology

November 21, 2023 — GE HealthCare has received U.S. FDA 510(k) Clearance for the new version of Digital Expert Access ...

Time November 21, 2023
arrow
News | Information Technology

November 14, 2023 — To help provide clinicians a comprehensive workflow, GE HealthCare is working towards the seamless ...

Time November 14, 2023
arrow
Subscribe Now