FDA Cleared New CT Imaging Technology, Method
For the first time in more than a decade, the US Food and Drug Administration (FDA) has cleared 2 new computed tomography (CT) imaging advancements for clinical use – the photo-counting CT detector (PCD-CT) and more recently, the brain CT image reconstruction method.
The PCD-CT, originally cleared for use on September 30, 2021, utilizes a 1-step process rather than the 2-step process of standard CT scans.1 This process allows the energy level of individual x-rays to be recorded, and allows for easier identification of different materials, such as iodinated blood, soft tissue, and bone.
The results from clinical studies indicated a 47% reduction in noise through this new technology. Further, the new technology lowered the amount of contrast agent needed for imaging by 30%. The PCD-CT also has better spatial resolution when compared with standard CT imaging systems.
Furthermore, the newly cleared method of brain CT image reconstruction utilizes artificial intelligence to reduce the amount of radiation patients are exposed to during CT scans of the brain. This method reduces the noise of CT perfusion scans to allow health care providers to administer lower radiation doses to patients without reducing the quality of the images.
Study results show that this new method reduced radiation doses by 50% to 75% when compared with standard methods. Current CT imaging devices are able to utilize brain CT image reconstruction without hardware updates.
“This is a prime example of a [National Institute of Biomedical Imaging] NIBIB-supported technology that translated into an FDA cleared product and can be used in clinical practice,” concluded Qi Duan, PhD, director of the Imaging Processing, Visual Perception and Display program, in a press release.2
- FDA clears first major imaging device advancement in computed tomography in nearly a decade. News release. US Food and Drug Administration; September 30, 2021. Accessed August 18, 2022. https://www.fda.gov/news-events/press-announcements/fda-clears-first-major-imaging-device-advancement-computed-tomography-nearly-decade
- Two monumental milestones achieved in CT imaging. News release. National Institute of Biomedical Imaging and Bioengineering; August 10, 2022. Accessed August 18, 2022. https://www.nibib.nih.gov/news-events/newsroom/two-monumental-milestones-achieved-ct-imaging