Positron and the Ochsner Clinic Foundation are planning to initiate a clinical study of the Affinity PET-CT imaging device.
Set to begin next week, the study will be guided by Dr Bober. He currently works at Ochsner Health System as director of molecular imaging and nuclear cardiology.
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The aim of the study is to obtain key data indicating the performance and efficacy of the imaging device.
During the study, the device will be evaluated along with several radiopharmaceuticals and new coronary flow software applications.
The study will follow the requirements of the Institutional Review Board and be registered as per the International Committee of Medical Journal Editors requirements.
Once the company receives the FDA’s investigational device exemption, it will begin an initial phase of the study involving phantom testing and subsequent imaging of human patients.
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By GlobalDataPositron will also submit a 510k and registration to the FDA to receive clearance for marketing and selling the device.
Positron president Adel Abdullah said: “The start of the clinical study with Dr Bober and the Ochsner Clinic is a significant milestone and one that sets all our plans in motion towards the launch of our PET-CT product.
“Now with Positron as the device manufacturer, we will oversee and direct the many details required for validation, FDA Clearance and the offering of our state-of-the-art PET-CT product to customers.
“Becoming the manufacturer required the transfer, organisation, preparation and review of thousands of pages of documentation for the company and FDA and although this was a long process it has worked to our benefit, placing Positron in the best position to capitalise on an expanding nuclear imaging industry that is seeking a molecular imaging scanner that best serves physicians, practices and patients.”
