Boston (SmartAboutHealth) - A new study released this week has put into question the approval process of cardiac devices by the U.S. Food and Drug Administration.
The new study was carried out by researchers from the University of California, San Francisco and was led by Dr. Rita Redberg. What they have found is that the approval of cardiovascular devices is often not tough enough to test the true ability of the devices.
The researchers found that many cardiac devices were approved based on just one study, and the studies were not as strict or tough as they should be in order to get the results that should be needed for approval.
Many of the studies that were run on the cardiac devices were found to not be randomized or blinded, meaning that they could have been easily fixed for approval.
The fear is that the studies could have been inaccurate in the way in which they were carried out.
The FDA released a statement Tuesday stating that this study of the clinical trials paint a picture of their work that is inaccurate.
Experts feel that the approval process for cardiac devices could be improved upon.








