Interior of a CT scanner
Interior of a CT scanner

Image source/Copyright: Deutscher Zukunftspreis/Ansgar Pudenz

News • Photon counting

Major CT advancement receives FDA clearance

The U.S. Food and Drug Administration (FDA) 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.”

Recommended article

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.

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 scanner 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 the device to Siemens Medical Solutions Inc.


Source: U.S. Food and Drug Administration

01.10.2021

Related articles

Photo

Sponsored • Earlier disease prediction and identification

The potential of AI in routine blood testing

It’s widely known that more than 70% of today’s medical decisions involve the results of laboratory tests, but the insights clinicians derive from these tests today may only be scratching the…

Photo

Sponsored • Siemens Naeotom Alpha

First CT scanner with photon-counting technology

Conventional CT imaging has reached its technical limitations: Resolution can only be improved by small margins and dose cannot be reduced significantly: Photon-counting technology enables drastic…

Photo

Sponsored • Photon-counting CT scanner

No detours, more detail

For the Siemens Healthineers team developing new and ever higher performing computed tomographs is daily fare. But when they introduced their most recent CT system an unusual sense of pride was…

Related products

Subscribe to Newsletter