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For Device Companies, Are FDA Headaches Ahead?

Executive Summary

Guidant Corp.'s failure to get an approval recommendation on July 10 from the FDA's Circulatory Systems Device panel for its Contak CD/Easytrak system to treat congestive heart failure certainly wasn't bad news for other players in cardiac rhythm management (CRM). But for those companies that don't compete directly with Guidant in CRM--and perhaps even for those that do--the push-back by the FDA panel raised some eyebrows. It's entirely possible that the Guidant device simply didn't measure up--that the panel was correct in judging that it didn't meet the clinical end-points required to recommend approval. But some device industry executives worry about the future direction of the FDA's approval process.


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