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Biosite Incorporated
U.S. FDA accepts application for tool to aid in stroke assessment, diagnosis
March 22nd, 2005
Biosite Incorporated (BSTE), a research-based provider of rapid medical diagnostics, announced the U.S. Food and Drug Administration (FDA) has notified the company that the agency has accepted the Triage Stroke Panel Premarket Approval Application (PMA) for further review. The panel is intended to be used as an aid in the assessment and diagnosis of cerebral ischemia (stroke). The Triage Stroke Panel consists of multiple biomarkers and utilizes a proprietary algorithm to calculate a single MultiMarker Index result. Biosite submitted its PMA for the Triage Stroke Panel in December 2004. The acceptance of the application reflects a threshold...
Source: Health Risk Factor Week (2005-03-22)
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