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Press Release

October 18, 2021
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FDA announces 510(k) clearance of photon-counting CT imaging device

Source:

Press Release

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The FDA has granted 510(k) clearance to Siemens Medical Solutions Inc. for the Siemens Naeotom Alpha, a new advancement in diagnostic CT imaging, according to a company press release.

The Naeotom Alpha is designed with photon-counting technology, which uses individual X-ray photons to provide physicians and trained staff with detailed information to aid in the diagnosis, treatment and planning of radiation therapy, according to the release.

“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 diagnostic X-ray systems for the FDA’s Center for Devices and Radiological Health, said in the release. “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,” Burk added.