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FDA Clears GE Healthcare's New Innova Digital Flat Panel Biplane Imaging Systems

Posted on: Tuesday, 14 March 2006, 12:00 CST

GE Healthcare announced today FDA 510(k) clearance for the Innova 3131(IQ) and 2121(IQ) digital flat panel Biplane Imaging Systems at the American College of Cardiology (ACC) annual scientific sessions in Atlanta, Georgia. These are the first and only systems available that will cover the full size of the patient's lateral and frontal anatomy simultaneously for a variety of cardiovascular and neurovascular image guided interventional procedures. This means that these procedures can be done with fewer x-ray images and contrast injections, both significant benefits for the patient. Both systems are indicated for use in cardiovascular imaging, diagnostic and interventional procedures, and three-dimensional imaging of vessels and soft tissue.

The Innova IQ platform is capable of imaging the finest vessels and cardiovascular anatomy based on the digital flat panel technology invented and developed by GE Healthcare for medical imaging. The unique image quality advantages of the GE panel also enable it to perform high quality 3D Flat Panel Rotational Imaging to produce three-dimensional images of the vascular system, bone and soft tissue in the body. With the 20cm and 30cm area coverage (the largest in the industry), the new Innova Biplane systems offer interventional radiologists and cardiologists a significant advantage over existing technology in performing a wide range of image-guided treatments.

"GE is dedicated to developing innovative technologies that improve the entire patient experience, from early and more accurate diagnosis to better treatment and management of diseases like atherosclerosis and a variety of neurologic conditions" said Laura King, vice president of the Global Interventional, Cardiology and Surgery business for GE Healthcare. "With the use of Biplane systems for cardiology, interventional radiology, and minimally-invasive therapeutic interventions, clinicians can now rely on Innova's excellent image quality, large detector size, and advanced technology that together set a new standard in interventional imaging."

With more than 1,200 Innova-family systems installed worldwide, more physicians rely on GE's Innova systems to help them diagnose and treat cardiovascular disease than any other all-digital flat panel system.

"The Innova digital biplane is the latest addition to a family of products whose design and features are based upon customer input from dozens of clinical studies," said King. "No other company offers a product like the Innova."

About GE Healthcare:

GE Healthcare provides transformational medical technologies and services that are shaping a new age of patient care. Our expertise in medical imaging and information technologies, medical diagnostics, patient monitoring systems, performance improvement, drug discovery, and biopharmaceutical manufacturing technologies is helping clinicians around the world re-imagine new ways to predict, diagnose, inform and treat disease, so their patients can live their lives to the fullest.

GE Healthcare's broad range of products and services enable healthcare providers to better diagnose and treat cancer, heart disease, neurological diseases, and other conditions earlier. Our vision for the future is to enable a new "early health" model of care focused on earlier diagnosis, pre-symptomatic disease detection and disease prevention. Headquartered in the United Kingdom, GE Healthcare is a $15 billion unit of General Electric Company (NYSE:GE). Worldwide, GE Healthcare employs more than 43,000 people committed to serving healthcare professionals and their patients in more than 100 countries. For more information about GE Healthcare, visit our website at www.gehealthcare.com.

Source: Business Wire

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