Siemen’s CT upgrade technology gets FDA clearance

USA -Just in time for the 50th anniversary of the first computed tomography (CT) scan, the US FDA announced that Siemens has received clearance for its new CT device, the first to use photon-counting technology.

This heralds the first major upgrade to CT technology in nearly a decade. The device was cleared via the 501(k) premarket pathway, which requires the submission to show that the new technology is as safe and effective as a legally marketed predicate device.

The Siemens NAEOTOM Alpha diagnostic imaging device provides more detailed information about a patient by utilizing an emerging CT technology that employs photon-counting detectors.

Siemens’ novel device makes use of a rapidly emerging CT technology known as photon-counting. Unlike current systems, which measure the total energy of a large number of X-rays at once, this new diagnostic device counts individual X-rays to provide more detailed information and images.

Computed tomography (also known as computerized tomography) is a non-invasive medical examination or procedure that produces cross-sectional images of the body using specialized X-ray equipment.

CT scans can be done on any part of the body for a variety of reasons. The CT system then converts these counts or measurements into recorded images that the healthcare provider reads and analyzes using complex software.

The technology has transformed the current two-step process of converting X-rays into visible light, which is then detected by a light sensor, into a single-step process of directly converting X-ray photons into digital electrical signals that are counted, producing into a detailed 3-D image with greater clarity and contrast.

The images generated by the Siemens NAEOTOM Alpha can be used to aid in diagnosis, treatment preparation, and radiotherapy planning by trained physicians and staff.

“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.

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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