Heart Ring Slips Through FDA Loophole

Merrill Goozner

First published 5/23/11 on GoozNews

The Chicago Tribune had an important series over the weekend exposing conflicts of interest in the cardiovascular medical device industry, and the loopholes in regulatory oversight that allowed what appears to be a dangerous heart valve replacement part to escape Food and Drug Administration scrutiny. The latter story is by far the more important one. Here’s the details, from the Trib website:

Instead of being grouped with heart valves and implantable pacemakers, annuloplasty rings were put into a class with most catheters, sutures and hearing aids, which allows the medical device industry to gain approval for new rings without clinical studies.

Continue reading “Heart Ring Slips Through FDA Loophole”