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O FDA cancela o software da comparação do raio X

por Brendon Nafziger, DOTmed News Associate Editor | January 11, 2012
Riverain Technologies' software that lets doctors compare old and new chest X-rays to look for lung cancer has received the Food and Drug Administration's 510(k) clearance.

The Dayton, Ohio-based company said doctors typically compare previous and current chest X-rays side by side to look for changes. But the new technology, called Temporal Comparison, registers the two scans to create a "difference image" that could make it easier for doctors to detect subtle changes.

In the company's FDA reader study, Riverain said using the technology 15 radiologists were better able to detect (a 12.4 percent increased sensitivity) actionable solitary pulmonary nodules in 422 pairs of chest X-rays, when compared against the traditional side-by-side studies.
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The technology, already cleared for sale in Europe and Canada, requires users to own the company's SoftView bone suppression software, which digitally removes bones from X-ray images, Riverain said on its website.

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