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FDA Clears First Advanced CT Imaging Device after a decade

Dr Kartikeya KohliBy Dr Kartikeya KohliPublished On 2021-10-01T07:10:48+05:30  |  Updated On 2021-10-01T14:17:01+05:30
FDA Clears First  Advanced CT Imaging Device after a decade

The US Food and Drug Administration has cleared the first new major technological improvement for Computed Tomography (CT) imaging in nearly a decade.The Food and drug administration has granted clearance of Siemens NAEOTOM Alpha to Siemens Medical Solutions Inc.The new diagnostic imaging device, called Siemens NAEOTOM Alpha, is designed to transform the information from X-ray photons that...

The US Food and Drug Administration has cleared the first new major technological improvement for Computed Tomography (CT) imaging in nearly a decade.

The Food and drug administration has granted clearance of Siemens NAEOTOM Alpha to Siemens Medical Solutions Inc.

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.
"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."
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.
Computed tomography (sometimes called computerized tomography) is a noninvasive medical examination or procedure that uses specialized X-ray equipment to produce cross-sectional images of the body. Each cross-sectional image represents a 'slice' of the person being imaged, not unlike the slices in a loaf of bread. These cross-sectional images are used for a variety of diagnostic and therapeutic purposes.
CT scans can be performed on every region of the body for a variety of reasons. The CT system then converts these counts or measurements through complex software into the recorded images the health care provider reads and analyzes.
The Food and Drug Administration reviewed the Siemens NAEOTOM Alpha 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.
Food and Drug Administration fda advanced ct computed tomography 
Dr Kartikeya Kohli
Dr Kartikeya Kohli

    Dr Kartikeya Kohli is an Internal Medicine Consultant at Sitaram Bhartia Hospital in Delhi with super speciality training in Nephrology. He has worked with various eminent hospitals like Indraprastha Apollo Hospital, Sir Gangaram Hospital. He holds an MBBS from Kasturba Medical College Manipal, DNB Internal Medicine, Post Graduate Diploma in Clinical Research and Business Development, Fellow DNB Nephrology, MRCP and ECFMG Certification. He has been closely associated with India Medical Association South Delhi Branch and Delhi Medical Association and has been organising continuing medical education programs on their behalf from time to time. Further he has been contributing medical articles for their newsletters as well. He is also associated with electronic media and TV for conduction and presentation of health programs. He has been associated with Medical Dialogues for last 3 years and contributing articles on regular basis.

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