番茄社区

FDA computer tomography (CT) scanner, which represents what the agency called the "first major imaging device advancement" in CT technology in close to a decade.

Naeotom Alpha utilizes so-called photon-counting detectors, an emerging technology that can "count" individual x-ray photons that pass through a patient and discriminate their energy, providing more detailed information to the CT reader. Current CT imaging systems are capable of measuring cumulative energy from numerous x-rays at once.

"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, PhD, of FDA's Center for Devices and Radiological Health, in a statement announcing the clearance on Thursday. "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."

Siemens has suggested that photon-counting CT scans can reduce for patients, as well as the need for contrast agents.

"In addition, physicians can work with images that visualize even very fine tissue structures, such as the smaller bronchi of the lungs or metastases in bones," the company noted.

Naeotom Alpha was okayed under FDA's 510(k) premarket clearance pathway, which requires demonstration that a new device is "substantially equivalent" to an already marketed predicate device.

Comment