FDA Watch: FDA Approves Enhanced Cologuard Cancer Test
Test maker Exact Sciences says it expects Cologuard Plus to cut false positives by more than 30 percent
Test maker Exact Sciences says it expects Cologuard Plus to cut false positives by more than 30 percent
Understanding the process and implementing proper procedures is the key to ensuring compliance when reporting such events
How three companies are addressing screening challenges with tests that help improve chances of early detection
How the current FDA AI/ML device regulations may be impeding innovation in the clinical lab
FDA seems determined to push ahead with final rule, regardless of CDRH director’s departure, hiring of replacement.