Fast, High Definition, Low Dose: GE Healthcare Announces FDA Clearance of Revolution CT

WAUKESHA, Wis., April 14, 2014 /PRNewswire/ -- GE Healthcare, a unit of General Electric Company (NYSE: GE), today announced U.S. FDA 510(k) clearance of its 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, over 70 million CT scans are done per year in the U.S. 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. The clinical impact:

• 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.

"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*⁰, 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. 

* Trademark of General Electric Company

^ Not yet CE market, not available for sale in all regions.

⁰ In clinical practice, the use of ASiR-V may reduce CT patient dose depending on the clinical task, patient size, anatomical location and clinical practice. A consultation with a radiologist and a physicist should be made to determine the appropriate dose to obtain diagnostic image quality for the particular clinical task.

About GE Healthcare 
GE Healthcare provides transformational medical technologies and services to meet the demand for increased access, enhanced quality and more affordable healthcare around the world.  GE (NYSE: GE) works on things that matter - great people and technologies taking on tough challenges. From medical imaging, software & IT, patient monitoring and diagnostics to drug discovery, biopharmaceutical manufacturing technologies and performance improvement solutions, GE Healthcare helps medical professionals deliver great healthcare to their patients.

SOURCE GE Healthcare