Software that Increases Visibility, Decreases Time to Confirm Placement of Lifesaving Medical Devices Receives CE Mark

DAYTON, Ohio – Nov. 23, 2012 – New software by Riverain Technologies that improves the visual clarity of conventional chest X-ray images and increases radiologists’ efficiency by reducing the time it takes to accurately confirm the proper placement of lifesaving feeding, drug delivery and pain management tubes and lines has received CE Mark approval.

The software, ClearRead +Confirm™, will be introduced at the 2012 Radiological Society of North America (RSNA) annual meeting in Chicago.

Tubes and lines placed inside the body are used regularly for intensive care patients and others receiving ongoing treatments for cancer, pain and other conditions. Improper placement or migration of the devices between uses can cause serious complications, including death.

Portable chest X-ray machines are routinely used to confirm placement of lines and tubes; however, the image quality makes it challenging for radiologists to differentiate these structures, and the rib and clavicle bones obscure visibility of chest tissue by up to 40 percent. Radiologists also incur significant time adjusting the image to make the edges and tips of the devices stand out.

ClearRead +Confirm™ software immediately processes any portable chest X-ray, creating a second, soft tissue image with the ribs and clavicles suppressed and increasing the contrast, sharpness and visibility of tubes, lines and cardiac wires. Radiologists simply toggle between the two images to confidently and efficiently confirm proper placement of the devices.

A Georgetown University reader study assessed the time it took radiologists to locate:

• PICC lines, or peripherally inserted central catheters, which are long, thin tubes that remain inside the chest to deliver nutrients, fluid, blood, and medicines over time to treat pain, infection or cancer. PICC lines also are used to draw blood samples and provide kidney dialysis.
• Nasogastric tubes (NG tubes), which carry food and medicine to the stomach through the nose.
• Wires that conduct or measure electrical impulses, including electrodes for cardiac pacing and defibrillation.

In the study, 334 chest X-rays were reviewed by 10 radiologists with and without the enhanced ClearRead +Confirm image. The software reduced the reading time by an average of nearly 19 percent, without comprising accuracy.

Evaluating the conventional X-ray and ClearRead image together took an average of 5 ½ seconds less per image than evaluating the conventional X-ray image on its own, amounting to a savings of 30 minutes across all images.

Participating radiologists strongly agreed that the enhanced image increased their confidence in confirming the placement of lines and tubes and made it easier to see venous catheters.

“The software-enhanced chest X-ray image increases radiologists’ confidence while reducing decision-making time and time to treatment, with no additional tests or radiation exposure for patients,” said Steve Worrell, Riverain’s Chief Technology Officer.

ClearRead +Confirm uses the clinically proven, proprietary machine learning and pattern recognition technologies in Riverain’s chest X-ray bone-suppression and computer-aided detection (CAD) software. ClearRead +Confirm software is cleared for sale in Europe and is currently being reviewed for clearance by the FDA.