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Boston Sci’s Watchman Stroke Device Finally Lands FDA Approval, With Favorable Labeling

This article was originally published in The Gray Sheet

Executive Summary

Three separate FDA advisory panels examined the clinical data supporting the left-atrial appendage closure device and struggled to identify exactly which patients it benefits. But FDA has finally approved Watchman with an indication that analysts say will support meaningful market action for Boston Scientific. Reimbursement policies, however, remain a question mark.

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