The Food and Drug Administration (FDA) has cleared the Siemens NAEOTOM Alpha device (Siemens Medical Solutions), a new technology for computed tomography (CT) imaging.

The NAEOTOM Alpha utilizes photon-counting detectors that measure each individual X-ray that passes through a patient’s body to create a detailed 3-dimensional image. According to Siemens, the benefits of photon-counting CT for patients include a reduction in radiation dose and less use of contrast agent. For clinicians, it is expected to provide CT data at high spatial resolution with improved image contrast.

The images produced by the device can be used by trained physicians and staff as an aid in diagnosis, treatment preparation and radiation therapy planning. 

“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 Laurel Burk, PhD, assistant director of the Diagnostic X-ray Systems Team in the FDA’s Center for Devices and Radiological Health.

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References

1. FDA clears first major imaging device advancement for computed tomography in nearly a decade. News release. US Food and Drug Administration. Accessed September 30, 2021. https://www.fda.gov/news-events/press-announcements/fda-clears-first-major-imaging-device-advancement-computed-tomography-nearly-decade. 
2. Photon-counting CT. Siemens Healthineers. Accessed October 1, 2021. https://www.siemens-healthineers.com/en-us/computed-tomography/technologies-and-innovations/photon-counting-ct.