FDA approves advanced CT imaging device

The Food and Drug Administration yesterday approved for marketing a computed tomography imaging device that uses advanced technology to help clinicians better diagnose and treat disease. The Siemens NAEOTOM Alpha device uses photon-counting detectors to measure each X-ray that passes through a patient's body, which can provide more useful information to clinicians than detectors that measure the total energy in many X-rays at once, FDA said.

“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, assistant director of the diagnostic X-ray systems team at FDA’s Center for Devices and Radiological Health.