Radialis announced today that it received FDA clearance for its Radialis PET Imager technology.
Thunder Bay, Ontario-based Radialis designed its advanced organ-targeted positron emission tomography (PET) system to produce functional images with high spatial resolution, expanding the insight available from molecular imaging.
According to a news release, the Radialis PET system can visualize any positron-emitting radiotracer, providing a promising option for imaging novel radiotracers targeting biomarkers in a specific organ. The small system footprint design allows for incorporation into existing nuclear medicine facilities to complement traditional PET/CT imaging, the company said.
Specifically developed for close-range, organ-targeted imaging, the system is comprised of a partial-ring planar PET camera, equipped with lutetium-containing gamma-ray detectors, which collect gamma rays emitted by injected positron-emitting radiopharmaceuticals. It generates images corresponding to the relative concentrations of the radiopharmaceuticals in the body.
The FDA indicated the system 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.