FDA approves R2 CAD for use with diagnostic mammograms

Computer-aided detection developer R2 Technology of Los Altos, CA, has received Food and Drug Administration clearance to expand the indications for its ImageChecker system to include diagnostic mammograms. ImageChecker was previously approved for use with routine screening mammograms.

As a result, ImageChecker will essentially be available for nearly every woman in the U.S. undergoing mammography, according to president and CEO Mike Klein. In 2001, approximately 34 million screening mammograms and 3.3 million diagnostic mammograms will be performed in the U.S., according to R2.

By AuntMinnie.com staff writers
June 13, 2001

Related Reading

Breast clinic to begin R2 CAD study, May 14, 2001

R2 lands Latin American distributor, March 29, 2001

Breast CAD system scores high sensitivity, lower specificity March 5, 2001

R2 lays plans to enter European mammography CAD market, March 4, 2001

R2 Technology hits million mark, March 1, 2001

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