FDAnews
www.fdanews.com/articles/174853-aytu-bioscience-wins-ce-mark-for-mioxsys-system

Aytu BioScience Wins CE Mark for MiOXSYS System

January 12, 2016

Aytu BioScience’s MiOXSYS system has been blessed with CE mark in the EU.

MiOXSYS is an in vitro diagnostic platform for assessing the level of oxidative stress in semen to help diagnose infertility in males.

The system reports oxidation-reduction potential as the key parameter, which effectively measures oxidative stress levels in semen and seminal fluid, according to Aytu.

The company added that it plans to initiate clinical trials of MiOXSYS in the U.S. for submission to the FDA. — Michael Cipriano