Prominent doctor raises concerns over change in heart devices

New York Times, December 11, 2008
Federal regulators are about to approve use of a critical new electrical component for implantable heart devices without adequately testing for its potential risks, says Robert G. Hauser, MD, of the Minneapolis Heart Institute in an article published in The New England Journal of Medicine. Hauser argues that manufacturers should perform at least some clinical trials on patients to ensure that the new technology is not prone to short-circuiting. Underlying Hauser's argument is a question that heart device producers, regulators, and lawmakers have been grappling with in recent years: When medical devices the FDA has already approved undergo technical changes, how much and what kind of additional testing should occur before they are allowed to be sold?

MOST POPULAR

SPONSORED REPORTS
SPONSORED HEADLINES

SIGN UP

FREE e-Newsletters Join the Council Subscribe to HL magazine

SPONSORSHIP & ADVERTISING

100 Winners Circle Suite 300
Brentwood, TN 37027

800-727-5257

About | Advertise | Terms of Use | Privacy Policy | Reprints/Permissions | Contact
© HealthLeaders Media 2015 a division of BLR All rights reserved.