This is the program for the 2010 Joint Statistical Meetings in Vancouver, British Columbia.

Abstract Details

Activity Number: 566
Type: Topic Contributed
Date/Time: Wednesday, August 4, 2010 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #307128
Title: Some Diagnostic Issues in Cardiovascular Device Studies
Author(s): Shanti Gomatam*+
Companies: FDA/CDRH
Address: 10903 New Hampshire Avenue , Silver Spring, MD, 20993-0002,
Keywords: Monitoring devices

The design of studies and the assessment of diagnostic performance have particular challenges in some classes of cardiovascular devices. Some specific examples are: monitoring devices that are intended to alert one of some impending cardiovascular event; devices where an in vivo reference standard measurement is not possible; and devices used for intravascular imaging. This work presents these challenges and discusses approaches to dealing with them.

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