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Medical industry taking hard look at software faults
Critics: Inadequate FDA testing for many vital high-tech devices
Chicago Tribune - Chicago, Ill.
Subjects: Medical device industry; Medical equipment; Software
Author: Mai-Duc, Christine
Date: Aug 31, 2011
Start Page: 19
Section: News
Abstract (Document Summary)

[...] many of the software-based devices -- including some insulin pumps, infusion pumps that deliver medicines or food to patients intravenously and defibrillators used in cardiac arrest -- are cleared by the Food and Drug Administration through an accelerated process that involves little or no clinical testing.

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