R2 Technology ImageChecker CT Lung CAD System Gets Approvable Letter
This article was originally published in The Gray Sheet
Executive Summary
R2 Technology expects to submit a data re-analysis of its ImageChecker CT lung computer-assisted detection system and gain FDA approval by the end of June, following receipt of an April 12 approvable letter
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R2 Technology
Board member William Mercer will serve as interim president/CEO of the computer-aided detection (CAD) firm until a permanent successor is found for outgoing chief exec Michael Klein, who has resigned. "As we strive to take R2 Technology towards its next phase as a full-fledged medical software company requiring heavy involvement in the soft copy or digital environment, Mike and the board agreed that the next generation of leadership would be needed," Mercer explained June 9. Mercer is a former president and CEO of Alaris Medical. R2, which provides CAD systems for breast cancer detection and has grown sales from $5 mil. to nearly $60 mil. over the past four years, received an FDA approvable letter for its ImageChecker CT lung nodule CAD system in April (1"The Gray Sheet" April 19, 2004, p. 26)...
R2 Technology
Board member William Mercer will serve as interim president/CEO of the computer-aided detection (CAD) firm until a permanent successor is found for outgoing chief exec Michael Klein, who has resigned. "As we strive to take R2 Technology towards its next phase as a full-fledged medical software company requiring heavy involvement in the soft copy or digital environment, Mike and the board agreed that the next generation of leadership would be needed," Mercer explained June 9. Mercer is a former president and CEO of Alaris Medical. R2, which provides CAD systems for breast cancer detection and has grown sales from $5 mil. to nearly $60 mil. over the past four years, received an FDA approvable letter for its ImageChecker CT lung nodule CAD system in April (1"The Gray Sheet" April 19, 2004, p. 26)...
R2 CAD Panel Conditions: Postmarket Clinical Efficacy Study, Data Reanalysis
A postmarket clinical efficacy study of R2 Technology's ImageChecker CT computer-aided detection (CAD) system for lung nodules should be a requirement for FDA approval, the agency's Radiological Devices Panel recommended Feb. 3