FDA Clears GE Healthcare's Revolution CT Scanner

General Electric Company unit GE Healthcare announced the U.S. Food and Drug Administration’s 510(k) clearance of Revolution CT, which converges best capabilities of spatial resolution, temporal resolution, and whole organ coverage in one CT scanner.

Steve Gray, president and CEO of GE Healthcare MICT, said, “This will be the first CT scanner that's right for physicians in every clinical specialty and provides answers from one CT exam. 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.”

Revolution CT includes 16 cm whole organ coverage and best-in-class spatial resolution via the new Gemstone Clarity Detector. Its technological advances also include a new gantry designed to image at 0.28s rotation speed. GE said its product’s clinical impact covers the following areas:

Cardiology - One beat, motion-free cardiac in high definition at any heart rate with or without beta blockers. This delivers the clinical information needed for the coronaries, myocardial perfusion and function with one contrast injection.

Oncology - Low dose, whole organ diagnosis and follow up of organs such as the liver, kidneys, pancreas, etc. are enabled by dynamic acquisition modes.

Neurology - Rapid, comprehensive stroke assessment with whole brain perfusion and dynamic CT angiography at very low dose.

The company said Revolution CT is able to address patients with CT challenges such as those with high heart rates, metallic implants, and those who are non-compliant. Revolution CT is able to freeze cardiac motion in one heartbeat, reduce metal artifacts, and offer sedation-free CT scanning. The system can also be used for sensitive patient groups such as pediatric, trauma, stroke, and renal insufficiency.

“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. Diagnostic quality images are now possible in challenging patients like those with high heart rates, which is a significant advancement,” said Dr. Ricardo C. Cury, chairman of Radiology and director of Cardiac Imaging at Baptist Health South Florida.

GE Healthcare said it plans to launch worldwide commercial shipments of Revolution CT this summer.