Radialis Garners FDA 510(k) Clearance for Portable PET Device

The Food and Drug Administration (FDA) has granted 510(k) clearance to the Radialis PET Imager, an emerging portable complement to traditional positron emission tomography/computed tomography (PET/CT) systems.

Specially designed for organ-targeted, close-range imaging, the Radialis PET Imager reportedly has increased sensitivity to radiotracer imaging agents, according to Radialis, the manufacturer of the device.

The company said the device combines a partial-ring plantar PET camera and lutetium-containing gamma ray detectors. The Radialis PET Imager can visualize any injected positron-emitting radiotracer agent and provide images of high spatial resolution, noted Radialis.

Radialis said the device also has two plantar detectors that can be adjusted as necessary to allow a variety of scans and adaptability to patients who are lying down, standing, or sitting. The portability of the 4.5 feet high device also facilitates smoother incorporation into existing nuclear medicine facilities, according to Radialis.