FDA Clears Siemens’ New CT Scanner With Photon-Counting Detector

The approval represents the first major technological advance in CT in nearly a decade.

Just in time to commemorate the 50th anniversary of the first computed tomography (CT) scan, the US FDA announced it has granted 510(k) clearance to Siemens for its new NAEOTOM Alpha CT device, the first to utilize photon-counting.

The emergence of photon-counting detectors represents the next significant enhancement to CT use, allowing for more detailed information about the patient to be obtained while creating images with less information that is deemed not useful for review and analysis. 

“About 15 years ago, work on photon-counting and its clinical vision started at Siemens Healthineers. We always believed in the tremendous clinical value and relentlessly worked on it together with our partners. We are excited that we have received FDA 510(k) clearance,” says André Hartung, Head of Diagnostic Imaging at Siemens Healthineers, in a statement.

By measuring each individual x-ray that passes through a patient’s body, photon-counting detectors can produce detailed three-dimensional images that can ultimately aid in making a diagnosis or treatment-related decisions. 

“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,” said Laurel Burk, Ph.D., assistant director of the Diagnostic X-ray Systems Team in the FDA’s Center for Devices and Radiological Health, in a statement. “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.”

The technology ultimately processes x-rays differently; transforming the current two-step process in which X-rays are converted into visible light, which is then detected by a light sensor, into a single-step process in which X-ray photons are directly converted into digital electrical signals that are counted, ultimately producing an image with greater clarity and contrast.