The US FDA has granted 510(k) clearance to GE Healthcare's Revolution CT, which will enable physicians to diagnose even the most challenging patients. This innovative technology provides uncompromised image quality and clinical capabilities through the convergence of coverage, spatial resolution and temporal resolution – all in one CT scanner.
Today, more than 70 million CT scans are done per year in the US with tremendous clinical value. However, CT still has challenges with patients that have high heart rate, metallic implants, and non-compliant patients. The Revolution CT is able to address these challenging patients by freezing cardiac motion in one heartbeat, reducing metal artifacts, and offering the potential for sedation-free CT scanning. The system also offers benefits for sensitive patient groups such as pediatric, renal insufficiency, trauma, and stroke.
“I had the opportunity to gather the clinical images for the submission of Revolution CT to the FDA and I have been impressed ever since,” said Dr. Ricardo C. Cury, chairman of Radiology and director of Cardiac Imaging at Baptist Health South Florida who served as principal investigator for gathering clinical images. “Diagnostic quality images are now possible in challenging patients like those with high heart rates, which is a significant advancement.”
Revolution CT’s convergence of technological advances include 16 cm whole organ coverage, best-in-class spatial resolution through the new Gemstone Clarity Detector, and a new gantry designed to image at 0.28s rotation speed and tested to support rotation speeds up to 0.2 sec in the future.
“This system should bring us to another level of image quality,” said Dr. Lawrence Tanenbaum. “With Revolution CT, I expect to see better routine images and more simple access to the more advanced procedures.”
ASiR-V, GE’s next generation of iterative reconstruction technology also recently cleared by U.S. FDA, is designed to deliver reduced noise levels, improve low-contrast detectability, and routinely reduce dose up to 82% for patients of all ages with uncompromised image quality. This especially benefits pediatric and other patients considered more sensitive to radiation exposure. Clinicians can reduce patient anxiety with Revolution CT’s Whisper Drive, soft ambient lighting, personalized gantry display, and bore pattern. Fast and low dose 70 kVp acquisitions for sedation free and minimal breath hold pediatric studies are also now possible.
“This will be the first CT scanner that’s right for physicians in every clinical specialty and provides answers from one CT exam” said Steve Gray, president and CEO of GE Healthcare MICT. “Revolution CT is able to scan even the most challenging patients, day in and day out, with remarkably clear images. It can also scan pediatric patients at very low doses. And, we made sure that using it is productive, logical, and intuitive.”
GE Healthcare plans worldwide commercial shipments of the Revolution CT this summer.