article_snippet: Can you imagine a prescription drug getting out on the market that didn't go through the approval process?" asked Dr. Steven Nissen, the chief of cardiovascular medicine at the Cleveland Clinic, who's testified to Congress about device safety problems.
article_snippet: Devices need to be regulated more vigorously.
article_snippet: According to FDA rules, a manufacturer must seek clearance for a new model if a manufacturer includes changes that "could significantly affect the safety or effectiveness of the device.
article_snippet: We believe the benefits outweigh the risks.
article_snippet: Diana Zuckerman, a device safety expert, said Diana Zuckerman, a device safety expert should.