VeraLook gets FDA OK

by Brendon Nafziger, DOTmed News Associate Editor | August 05, 2010
VeraLook is coming to the U.S.A.
Software that helps radiologists interpret images gleaned from virtual colonoscopies received U.S. Food and Drug Administration clearance, its developer iCAD said Wednesday.

The computer-aided detection program, VeraLook CAD, helps find and mark possible polyps in the colon discovered during CT colonographies.

“As with breast and prostate cancer detection, computer-aided detection for virtual colonoscopy will help us find more cancers at an earlier stage,” University of Chicago radiology professor Dr. Abraham Dachman offered in a statement.

Nashua, N.H.-based iCAD's stock surged after the announcement, rising 18 percent to reach $2.27 a share on Nasdaq in trading Wednesday.

iCAD plans to sell VeraLook through its OEM partners, iCAD’s CEO Ken Ferry said.

While “technically available” from Stony Brook, N.Y.-based Viantroix Inc., which already markets VeraLook abroad, the software should be fully commercially available in the United States by the fourth quarter, he said.

“It’s probably a couple of months before our other partners are online,” Ferry told DOTMed News.

The product, which debuted at the European College of Radiology’s 2009 meeting in Vienna, has been commercially available in Europe and Canada since last year. In fact, in Europe, it has even received an update.

A new version of the software that provides a 5 percent increase in sensitivity for polyp detection, and a 20 percent cut in false positives, launched at the European Society of Gastrointestinal and Abdominal Radiology in Dresden, Germany in June, iCAD said in a May press release.