FDA Clears First Major Imaging Device Advancement for Computed Tomography in Nearly a Decade

SILVER SPRING, Md., Sept. 30, 2021 /PRNewswire/ -- Today, the U.S. Food and Drug Administration cleared the first new major technological improvement for Computed Tomography (CT) imaging in nearly a decade.

"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, Ph.D., assistant director of the Diagnostic X-ray Systems Team in the FDA's Center for Devices and Radiological Health. "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 device uses the emerging CT technology of photon-counting detectors which can measure each individual X-ray that passes through a patient's body, as opposed to current systems which use detectors that measure the total energy contained in many X-rays at once. By 'counting' each individual X-ray photon, more detailed information about the patient can be obtained and used to create images with less information that is not useful in the review and analysis.

Computed tomography (sometimes called computerized tomography) is a noninvasive medical examination or procedure that uses specialized X-ray equipment to produce cross-sectional images of the body. Each cross-sectional image represents a 'slice' of the person being imaged, not unlike the slices in a loaf of bread. These cross-sectional images are used for a variety of diagnostic and therapeutic purposes.

CT scans can be performed on every region of the body for a variety of reasons. The CT system then converts these counts or measurements through complex software into the recorded images the health care provider reads and analyzes. 

The new diagnostic imaging device, called Siemens NAEOTOM Alpha, 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 3-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.

The FDA reviewed the Siemens NAEOTOM Alpha through the 510(k) premarket clearance pathway. A 510(k) is a premarket submission made to the FDA to demonstrate that a new device is substantially equivalent to a legally marketed predicate device.

The FDA granted clearance of Siemens NAEOTOM Alpha to Siemens Medical Solutions Inc.

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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

SOURCE U.S. Food and Drug Administration