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Radialis PET Imager Receives FDA Clearance

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Radialis Inc. announces it has received FDA clearance to market the Radialis PET Imager, an advanced organ-targeted positron emission tomography (PET) system, in the United States.

The heightened sensitivity of the Radialis PET Imager to radiotracer enables the system to produce functional images with high spatial resolution, expanding the insight available from molecular imaging. Able to visualize any positron-emitting radiotracer, the system is particularly promising for imaging novel radiotracers targeting biomarkers in a specific organ. The small system footprint allows it to be incorporated into existing nuclear medicine facilities to complement traditional PET/CT.

Cleared Indications for Use:

The Radialis PET Imager is intended for medical purposes to image and measure the distribution of injected positron emitting radiopharmaceuticals in human beings for the purpose of determining various metabolic and physiologic functions within the human body.

Cleared Device Description:

The Radialis PET Imager is a high spatial resolution, small field-of-view PET imaging camera specifically developed for close-range, organ-targeted (i.e., limited field) imaging. The Radialis PET Imager is a partial-ring planar PET camera, equipped with lutetium-containing gamma-ray detectors, which collect gamma rays emitted by injected positron-emitting radiopharmaceuticals, and generates images corresponding to the relative concentrations of these radiopharmaceuticals in the body. The Radialis PET Imager is designed to collect gamma rays emitted by the injected radiopharmaceutical in a patient’s body part with high efficiency.

 

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