The U.S. FDA says that it has granted 510(k) premarket clearance to what it deems the “first new major technological improvement for CT imaging in nearly a decade.” The scanner, Malvern, Pa.-based Siemens Healthineers’ Naeotom Alpha, is designed to transform the information from x-ray photons that pass through a patient’s body, and are received by a detector, into a detailed 3D image.
The device uses the emerging CT technology of photon-counting detectors. which can 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. By ‘counting’ each individual x-ray photon, more detailed information about the patient can be obtained and used to create images with less information that is not useful in the review and analysis, according to the FDA.
“Computed tomography is an important medical imaging tool that can aid in diagnosing disease, trauma or abnormality; planning and guiding interventional or therapeutic procedures; and monitoring the effectiveness of certain therapies,” sahs Laurel Burk, PhD, assistant director of the diagnostic x-ray systems team in the FDA’s Center for Devices and Radiological Health.
“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,” Burk adds.
The FDA reviewed the Siemens Naeotom Alpha through the 510(k) premarket clearance pathway. A 510(k) is a premarket submission made to the FDA to demonstrate that a new device is substantially equivalent to a legally marketed predicate device.