FDA clears first major breakthrough in computed tomography imaging devices in nearly a decade
SPRING SILVER, Md., September 30, 2021 / PRNewswire / – Today, the United States Food and Drug Administration authorized the first major new technological improvement for computed tomography (CT) imaging in nearly a decade.
âComputed tomography is an important medical imaging tool that can help diagnose disease, trauma or abnormality; plan and guide interventional or therapeutic procedures; and monitor the effectiveness of certain therapies, âsaid Laurier Burk, Ph.D., deputy director of the X-ray diagnostic systems team at the Center for Devices and Radiological Health, FDA. “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 the areas of scientific and diagnostic advancement.”
The device uses emerging CT technology of photon counting detectors that can measure each individual x-ray that passes through a patient’s body, as opposed to current systems that use detectors that measure the total energy contained in many rays. X at a time. 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 examination and analysis.
Computed tomography (sometimes called a CT scan) is a non-invasive 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 photographed, much like the slices of a loaf of bread. These cross-sectional images are used for various diagnostic and therapeutic purposes.
CT scans can be done on all areas of the body for a variety of reasons. The CT system then converts these counts or measurements through complex software into recorded images that the healthcare provider reads and analyzes.
The new diagnostic imaging device, called Siemens NAEOTOM Alpha, is designed to transform information from x-ray photons that pass through a patient’s body and are received by a detector, into a detailed three-dimensional image. The images delivered by the system can be used by a qualified physician as a diagnostic aid or can be used by trained personnel as an aid in diagnosis, treatment preparation and radiation therapy planning.
The FDA has reviewed the Siemens NAEOTOM Alpha via the 510 (k) pre-market clearance pathway. A 510 (k) is a pre-market submission made to the FDA to demonstrate that a new device is substantially equivalent to a legally marketed predicate device.
The FDA has granted Siemens NAEOTOM Alpha clearance to Siemens Medical Solutions Inc.
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SOURCE US Food and Drug Administration