The U.S. Food and Drug Administration has awarded clearance to what it says is the first major upgrade to CT technology in nearly a decade.
The FDA’s 510(k) designation applies to the NAEOTOM Alpha imaging tool from Siemens Medical Solutions Inc., the administration announced Sept. 30.
Siemens’ novel device utilizes a fast-emerging CT technology known as photon-counting. Unlike current systems that measure the total energy from many X-rays at once, this new tool counts individual X-rays for more detailed information and images.
The FDA’s Center for Devices and Radiological Health touted the advancement in an alert sent out Thursday morning.
“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, PhD, assistant director of the FDA center’s Diagnostic X-ray Systems Team. “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.”
Trained physicians can use the system to guide diagnostic decisions, prepare treatments and plan radiation therapy, according to the announcement.
Read more about the system here.