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CAD Mammography Leads To Unnecessary Patient Recalls, Biopsies – ECRI

This article was originally published in The Gray Sheet

Executive Summary

An ECRI Institute evidence report released Dec. 15 on computer-aided detection mammography finds that while the technology does correctly diagnose breast cancer in some cases, its use led to patient callbacks in which the vast majority of women were actually healthy

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FDA Refines Requirements For Computer-Aided Detection

FDA published two draft guidance documents Oct. 21 to help firms through 510(k) or PMA submissions for computer-aided detection tools; on the following day, the agency announced an upcoming panel meeting on the topic

FDA Refines Requirements For Computer-Aided Detection

FDA published two draft guidance documents Oct. 21 to help firms through 510(k) or PMA submissions for computer-aided detection tools; on the following day, the agency announced an upcoming panel meeting on the topic

Research In Brief

Central line infections decline: The incidence of methicillin-resistant Staphylococcus aureus (MRSA) central line-associated bloodstream infections in U.S. intensive care units decreased almost 50% between 1997 and 2007, according to data reported by hospitals to the Centers for Disease Control and Prevention (CDC). A study in the Feb. 18 Journal of the American Medical Association looked at 33,587 reports of central line-associated bloodstream infections at 1,684 intensive care units, representing more than 16 million patient-days of surveillance between 1997 and 2007. Although the decline in infections may be encouraging, Veterans Administration infectious disease expert Michael William Climo warns in an accompanying editorial that "the study also leaves the unsettling realization that the observed reductions in infection cannot be attributed to any particular intervention." He observes that most ICUs did not have a MRSA screening program in place in 2001 when the decline began. This finding must be considered as the public and industry are pushing for expanded MRSA screening and adoption of newer, more expensive technologies such as polymerase chain reaction-based MRSA screening

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