Siemens’ Naeotom Alpha Imaging Device Cleared; FDA Hails ‘Major Advancement’

The FDA has granted 510(k) clearance to Siemens’ Naeotom Alpha, which the agency called “the first new major technological improvement” for computed tomography (CT) imaging in nearly a decade.

The innovative device uses photon-counting detectors to measure each individual x-ray that passes through a patient's body, as opposed to current systems, which use detectors that measure the total energy contained in many x-rays at once. The technique makes it possible to compile more detailed information about the patient and use it to create richer, 3D images.

The images the Naeotom Alpha produces can be used by healthcare providers for diagnosis, treatment preparation and radiation therapy planning.