Devices FDA Radiology

 News Release - June 21, 2010

U.S. FDA Approves Improved Performance of Riverain Medical's OnGuard Chest X-ray Computer-Aided Detection Technology

New version of OnGuard computer-aided detection technology boasts 50% relative improvement in sensitivity and 73% reduction in false positive marks

DAYTON, Ohio, June 21 -- (Healthcare Sales & Marketing Network) -- Riverain Medical® announced today that the U.S. Food and Drug Administration (FDA) has granted approval for the newest version of the OnGuard™ Chest X-ray computer-aided detection (CAD) technology. OnGuard identifies solitary pulmonary nodules that may represent early-stage lung cancer on an existing chest X-ray (1). This improved performance demonstrates a 73% reduction in false positive marks and 50% higher relative sensitivity compared to the original product (2).

More than 200,000 Americans will be diagnosed with lung cancer this year. Only a small percentage of these patients will be diagnosed with lung cancer in the earliest stages when it is most treatable. When lung cancer is detected early, five-year survival rates triple (3). Multiple studies demonstrate that OnGuard can detect 37-50% of lung cancers that were missed in the initial interpretation (4),(5).

"Our published studies demonstrate that OnGuard can detect up to 50% of the lung cancers that were missed in the initial interpretation," says Dr. Charles White, Professor and Vice Chairman of Radiology at the University of Maryland School of Medicine. "OnGuard provides physicians with a tool to help identify suspicious nodules in the lungs earlier."

OnGuard uses pattern recognition and machine learning technology to detect nodules. Well centered, scaled markers are then placed around regions of interest that may be early-stage lung cancer. Because OnGuard utilizes the existing digital chest X-ray, there is no additional radiation dose, patient procedure, hardware or stand-alone workstation needed to integrate the technology into any radiology department.

"OnGuard can make a difference in the fight against lung cancer," explains Diane Hirakawa, CEO and Chairman of Riverain Medical. "This technology can improve the detection of lung cancer in its earliest stages when treatments are most effective."

About Riverain Medical

Dayton, Ohio based medical technology innovator Riverain Medical develops practical solutions to save and improve the quality of people's lives, through the early detection of disease. The company's technologies are designed to enhance the expert skills of physicians to improve patient outcomes without additional radiation dose or procedures.

(1) http://lungcancer.about.com/od/typesoflungcancer/a/spn.htm

(2) Riverain Medical Clinical Trial for U.S. FDA Submission

(3) American Cancer Society Facts and Figures 2010

(4) C. White, T. Flukinger, J. Jeudy and J. Chen (2009). Use of a computer-aided detection System to Detect Missed Lung Cancer at Chest Radiography. Radiology. 252: 273-281.

(5) F. Li, R. Englemann, C. Metz, K. Doi and H. MacMahon (2008). Lung Cancers Missed on Chest Radiographs: Results Obtained with a Commercial computer-aided detection Program. Radiology. 246: 273-280.

Source: Riverain Medical

Issuer of this News Release is solely responsible for its content.
Please address inquiries directly to the issuing company.