Siemens Medical Solutions has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its new diagnostic imaging device called Siemens NAEOTOM Alpha.
The new diagnostic imaging device transforms the information from X-ray photons, which pass through a patient’s body, into a detailed three-dimensional image. They are received by a detector.
As opposed to current systems that use detectors that measure the total energy contained in many X-rays at once, the emerging computed tomography (CT) technology of photon-counting detectors is used by the new device to measure each individual X-ray that passes via patient’s body.
CT is a noninvasive medical examination or procedure, which uses specialised X-ray equipment to generate cross-sectional images of the body.
The images delivered by Siemens NAEOTOM Alpha enables a trained physician to use them as an aid in diagnosis. Trained staff can also use them as an aid in diagnosis, treatment preparation and radiation therapy planning.
The FDA’s Centre for Devices and Radiological Health’s diagnostic X-ray systems team assistant director Dr Laurel Burk said: “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.
“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.”
In February this year, Siemens secured approval from the European Commission (EC) for the acquisition of cancer care technologies and solutions provider Varian Medical Systems.
Varian offers various advanced products for use in different applications, including radiosurgery, radiotherapy, proton therapy and brachytherapy.
