Opinion: Diagnostic innovations are slowed by bureaucratic roadblocks
It's a long and winding road to bringing diagnostic innovations to the U.S. market. We need to clear the roadblocks.
Imagine, for a minute, that you are a cardiologist working in the emergency department of a busy hospital. You have several patients with chest pain: some of them are having heart attacks, or are about to; others have heartburn or muscle strains. It would be great to have a diagnostic tool that quickly and accurately tells one from the other.
Physicians outside the U.S. could already have access to this type of diagnostic test. But in the U.S. it’s still pending clearance by the Food and Drug Administration. FDA-required processes for a new commercial test to gain approval for marketing and use can be costly and take years, depending on how complicated a test is.
This raises the question: Should we be making it easier for companies to bring
