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.
![A 53-year-old patient (patient number four) with a recurrent pituitary adenoma with extension of a cystic component of disease to the medial temporal lobe apparent on MRI (contoured in blue), and extension of disease to the left sphenoid bone and orbital apex apparent on [68Ga]Ga-DOTA-TATE (contoured in yellow).](https://img.auntminnie.com/mindful/smg/workspaces/default/uploads/2026/04/pituitary-tumor.QGsEnyB4bU.jpg?auto=format%2Ccompress&dpr=2&fit=crop&h=167&q=70&w=250)
