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Riverain Technologies’ Temporal Comparison X-ray Software Receives FDA Clearance

January 12, 2012 By AxoGen, Inc.

DAYTON, Ohio–(BUSINESS
WIRE
)–Riverain Technologies announced today that it has received
510(k) clearance from the Food and Drug Administration (FDA) for its Temporal Comparison software. This software electronically
compares current and prior chest X-ray images and can help identify nodules
that may be early-stage lung cancer, when there are more treatment options.

The first-of-its-kind technology zeros in on differences
between current and prior chest X-rays of the same patient, drawing attention
to what may be an emerging or enlarging tumor. The software aligns and
registers the two patient images to produce a difference image, which allows
radiologists to pinpoint even subtle changes that show up more clearly than on
a traditional X-ray. Temporal Comparison also has received approval for
marketing in the European Union.

In a study of 422 pairs of chest X-rays, 15 radiologists
were able to demonstrate an average 12.4 percent improvement in sensitivity for
actionable solitary pulmonary nodules using Riverains Temporal Comparison
software as compared to results based on comparing the X-rays side by side,
todays standard.1

At present, doctors place current and previous X-rays side
by side to determine if there are changes in the lung tissue. Growths or
infections show up in gradations of white, as do bones, the heart and other
structures, making it difficult to detect changes, especially subtle ones.
Riverains Bone Suppression software removes the bones from the image, then
Riverains Temporal Comparison software accentuates changes between the two
images, making any differences more conspicuous.

“Lung tissue is very complex and it can be quite difficult
to see changes, particularly in certain areas, such as the hilum and apices
where vascular structures and bones come together,” said Steve Worrell, Chief
Technology Officer at Riverain. “The Temporal Comparison software is
particularly helpful to radiologists in detecting changes in those areas.”

The groundbreaking combination of Riverains Bone
Suppression and Temporal Comparison technologies also can be used with
Riverains Computer-Aided Detection (CAD) to improve early detection of lung
disease.

1 Riverain Medical DeltaView FDA 510(k) Reader Study Results
2011

Riverain Technologies

Riverain Technologies, formerly Riverain Medical, is a Dayton, Ohio-based
medical technology innovator that develops practical solutions to save and
improve the quality of peoples lives through the early detection of disease.
The companys technologies are designed to enhance the expert skills of
radiologists to improve patient outcomes without additional radiation dose or
procedures. For more information please visit: www.riveraintech.com.

Posted by Sean Fenske, Editor-in-Chief, MDT

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