Radialis seeks FDA clearance for new PET camera

2016 09 02 09 36 05 93 Fda Logo V2 400

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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