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
|
|
Abstract:
|
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.
|
The address information is for the authors that have a + after their name.
Authors who are presenting talks have a * after their name.
Back to the full JSM 2010 program
|
2010 JSM Online Program Home
For information, contact jsm@amstat.org or phone (888) 231-3473.
If you have questions about the Continuing Education program, please contact the Education Department.