www.fdanews.com/articles/175976-health-canada-approves-aytu-biosciences-mioxsys-system
Health Canada Approves Aytu Bioscience’s MiOXSYS System
March 31, 2016
Aytu Bioscience has gained Health Canada II medical device approval for its MIOXSYS system, intended to evaluate oxidative stress in semen to better diagnose male infertility.
The system nabbed CE mark approval in January, and the company also plans to pursue FDA clearance.
Aytu Bioscience is based in Englewood, Colorado, and specializes in urology products that target prostate cancer, urinary tract infections, male infertility and male sexual dysfunction. — Anisa Jibrell