Radialis seeks FDA clearance for new PET camera

By AuntMinnie.com staff writers

September 16, 2021 -- Radialis Medical has applied for U.S. Food and Drug Administration (FDA) 510(k) clearance for its Radialis PET camera for organ-based imaging.

The Radialis PET camera is an organ-targeted PET system that positions detectors in close proximity to the organ of interest for a higher-quality image with a smaller field of view, the company said. In addition, the camera's detector electronics include integrated cooling to enhance signal quality and high-throughput data acquisition that's optimized for low-dose imaging.

The Radialis camera would be an ideal addition to clinics with whole-body PET systems due to its improved sensitivity, spatial resolution, and flexibility, which enable precision imaging of multiple organs, the company said.

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