Riverain Technologies (Dayton, OH, USA) reported that it has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Temporal Comparison software. The first-of-its-kind technology targets 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 generate a difference image, which allows radiologists to pinpoint even subtle alterations that appear more clearly than on a conventional 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 show an average 12.4% improvement in sensitivity for actionable solitary pulmonary nodules using Riverain’s Temporal Comparison software as compared to results based on comparing the X-rays side by side, today’s standard (Riverain Medical DeltaView FDA 510(k) Reader Study Results 2011).

At present, clinicians position current and previous X-rays side by side to determine if there are changes in the lung tissue. Growths or infections appear as gradations of white, as do bones, the heart, and other structures, making it difficult to detect changes, particularly subtle ones.

Riverain’s Bone Suppression software removes the bones from the image, and then the Temporal Comparison software highlights changes between the two images, making any differences more obvious. “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 combination of Riverain’s Bone Suppression and Temporal Comparison technologies also can be used with Riverain’s computer-aided detection (CAD) to improve early detection of lung disease.

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