With the certification, the Silicon Valley-based company aims to roll out its AvaGen test for keratoconus and corneal dystrophies beginning this quarter.
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.
The firm said that its newly CE-marked test for intestinal infections is suitable for use in laboratories and hospitals, and provides results in 90 minutes.
