Siemens Healthineers Naeotom Alpha Photon-Counting CT Technology Cleared by FDA

September 30, 2021—Siemens Healthineers announced FDA 510(k) clearance of the Naeotom Alpha, a photon-counting CT. The Naeotom Alpha’s photon-counting detector’s active detection layer consists of a cadmium telluride one crystal, providing advantages over conventional CT detectors.

The company explained that standard CT detectors convert the x-rays in a two-step process: first into visible light that is subsequently detected by a light sensor, ultimately producing the final image. Because of this intermediate step, important information about the energy of the x-rays is lost and no longer available to aid in diagnosis; contrast is reduced, and images lack clarity.

Siemens Healthineers’ photon-counting CT detector no longer converts the x-rays into visible light. Instead, the x-ray photons are converted directly into completely digital electrical signals and then counted without information loss. This significantly adds new clinically relevant information and improves image sharpness and contrast.

André Hartung, Head of Diagnostic Imaging at Siemens Healthineers, commented in the company’s press release, “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.”

The company advised that it will present additional information about this technology at the Siemens Healthineers SHAPE 22 event on November 15, 2021.

In a separate announcement from the FDA, Laurel Burk, PhD, Assistant Director of the Diagnostic X-ray Systems Team in the FDA’s Center for Devices and Radiological Health, stated, “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. 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 FDA noted that the Siemens Naeotom Alpha diagnostic imaging device 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 three-dimensional image. The images delivered by the system can be used by a trained physician as an aid in diagnosis or can be used by trained staff as an aid in diagnosis, treatment preparation and radiation therapy planning.