FujiFilm Nets FDA Clearance for Compact 128-Slice CT System

FUJIFILM Healthcare Americas Corporation has received FDA 510(k) clearance for its new compact, 128-slice computed tomography (CT) system, the FCT iStream. The system employs four core proprietary Fujifilm technologies, including HiMAR Plus (High image quality Metal Artifact Reduction), Intelli IPV, SynergyDrive and IntelliODM to enhance the sharpness of images, streamline workflow through AI automation, and significantly reduce patient dose.

There is a clear need to decrease patient radiation dose as much as possible during imaging, including CT scans. The FCT iStream CT system comes equipped with several technologies that drive down patient dose, including Fujifilm’s IntelliODM, an-organ based dose modulation reduction technique which modulates radiation dose in angular and/or slice directions based on patient attenuation. Additionally, Fujifilm’s IntelliEC feature helps further reduce patient dose for all CT scanning, including cardiac imaging. Intelli IPV, Fujifilm’s proprietary iterative progressive reconstruction with visual modeling (IPV) method, is another innovative technology that enhances sharpness by reducing noise by up to 90% and provides up to 83% reduced patient dose.

To streamline technologist workflow, the system captures 60 images per second and leverages Fujifilm’s SynergyDrive technology to automate, simplify and accelerate the scanning process. SynergyDrive helps streamline the entire image capture process, assisting with automating positioning of the patient inside the CT system, mapping imaging parameters on where to scan, and scanning and archiving the images.

“Staff shortages, increased financial pressure and escalating patient demand are driving radiology departments to look for ways to streamline workflow, avoid repeat scans and ensure they are maximizing throughput,” said Shawn Etheridge, executive director, modality solutions, FUJIFILM Healthcare Americas Corporation. “We’ve designed FCT iStream to reduce the pain points these high-volume departments face by engineering an intelligent, reliable, imaging solution that will help automate clinician’s most time-consuming steps.”

Scanning patients with metal implants can distort CT images, making it difficult to clearly visualize details in and around them. To help clinicians obtain clear, high-quality images for patients with metal implants, FCT iStream leverages HiMAR Plus (High image quality Metal Artifact Reduction) technology to detect and correct corrupted data from the metal in the images. Unlike traditional methods, it combines both projection-based and image-based correction. This results in improved image quality throughout the anatomy, while clarifying metal implants and surrounding tissue.