Daily Newsletter

11 September 2023

Daily Newsletter

11 September 2023

Positron and Ochsner Clinic to initiate study of imaging device

The study will be registered as per the International Committee of Medical Journal Editors requirements.

September 11 2023

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.

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.

Positron 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.”

Generative AI set to transform the medical devices industry

Generative AI can improve personalized healthcare by collecting data from patients via wearable devices, which can provide continuous, real-time data that can complement traditional data sources such as imaging, patient records, and more. It can also enhance existing imaging techniques by generating high-quality images of organs using data from low-resolution images (such as ultrasounds). However, the collection and use of patient healthcare data through AI medical products could conflict with regulations around the globe.

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