The US Food and Drug Administration (FDA) has cleared the first major technological improvement for CT in nearly a decade, the agency said in a statement September 30.
The diagnostic imaging device, Siemens NAEOTOM Alpha, provides more detailed information about a patient by using an emerging CT technology that involves photon-counting detectors. Whereas current CT technology detects the total energy in multiple x-rays at one time, photon-counting detectors measure the individual x-rays that pass through a patient’s body. The technology creates images with “less information that is not useful in the review or analysis,” the FDA noted in its statement. The images produced by the Siemens NAEOTOM Alpha can be used by trained physicians and staff to assist in diagnosis, treatment preparation, and radiotherapy planning.
The device was cleared through the 501(k) premarket pathway, which requires the submission to demonstrate that the new technology is as safe and effective as an already legally marketed predicate device.
“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,” Laurel Burk, PhD, assistant director of the diagnostic x-ray systems team in the FDA’s Center for Devices and Radiological Health, said in the statement. The agency’s decision to clear the device “underscores the FDA’s efforts to encourage innovation in areas of scientific and diagnostic progress,” she added.
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