FDA announced today that it has cleared Siemens Healthineers’ Naeotom Alpha, describing the device as the first major computed tomography advancement in nearly a decade.
The Naeotom Alpha uses the emerging CT technology of photon-counting detectors. The sensors measure each X-ray that passes through a person’s body. Previously, CT detectors have measured the total energy contained in many X-rays at once.
“Counting” each individual X-ray photon enables more detailed 3D imagery about what is going on inside a patient.
FDA official Laurel Burk noted in an FDA news release that computed tomography is an important medical imaging tool that can aid in diagnosing disease, trauma or abnormality. CT also aids in the planning and guiding of interventional or therapeutic procedures, as well as monitoring the effectiveness of certain therapies.
“Today’s action represents the first major new technology for computed tomography imaging in nearly a decade and underscores the FDA’s efforts to encourage innovation in areas of scientific and diagnostic progress,” said Burk, who is assistant director of the Diagnostic X-ray Systems Team in the FDA’s Center for Devices and Radiological Health.