July 19, 2022 — Radialis Inc. today announced that it has received clearance to market the Radialis PET Imager, an organ-targetedpositron emission tomography(PET) system, in the United States.
The advanced 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 traditionalPET/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
Radialis PET成像仪是一种高空间分辨率、小视野PET成像相机，专门用于近距离、器官瞄准(即有限视野)成像。Radialis PET成像仪是一种偏环平面PET相机，装有含镥的伽马射线探测器，收集注射的正电子放射药物发出的伽马射线，并生成与这些放射药物在体内相对浓度相对应的图像。Radialis PET成像仪设计用于高效收集患者身体部位注射的放射性药物发出的伽马射线。
For more information:www.radialis.com
August 10, 2022
