The latest regulatory news and FDA approvals.
With the certification, the Silicon Valley-based company aims to roll out its AvaGen test for keratoconus and corneal dystrophies beginning this quarter.
The Berlin-based company is the first to be designated and more NBs expect they will be designated by year end.
The test, which detects antibodies to Ebola virus from whole-blood samples and cadaveric oral fluid, was also granted breakthrough device designation.
While some groups have communicated their concerns directly to the agency, stakeholders have also formed a new coalition to publicly take issue with FDA's actions.
Fresenius was alleged to have unnecessarily tested some dialysis patients for hepatitis B surface antigen and billing Medicare for the tests.