Radialis Gets 510(k) Clearance for Organ-Targeted PET System

Radialis has received a 510(k) clearance from the FDA for its organ-targeted positron emission tomography (PET) system called the PET Imager.

The device is used to image and measure the distribution of injected positron emitting radiopharmaceuticals to determine various metabolic and physiologic functions.

The high resolution and small field-of-view PET imaging camera is designed for close-range imaging. It is also equipped with gamma-ray detectors, which generate images corresponding to the relative concentrations of the PET drugs.

The imager can provide targeted early detection across a broad range of diseases and can help those most at risk in addition to those who have early onset of a specific disease, the company said.