www.fdanews.com/articles/175924-anika-therapeutics-nabs-ce-mark-approval
Anika Therapeutics Nabs CE Mark Approval
March 28, 2016
Bedford, Mass.-based Anika Therapeutics has received the CE mark for its combination viscosupplement Cingal for the treatment of osteoarthritis of the knee.
In clinical trials, the device — which is administered by injection — demonstrated superiority over placebo at 12 weeks and patients experienced improvement in stiffness and physical function at 26 weeks, the company says.
Previously, Cingal was approved in Canada, and the company is pursuing a sign-off by the FDA. — Anisa Jibrell