Mainstay Set To Launch ReActiv8 Neurostimulator In Germany

Mainstay Medical is ready to launch its ReActiv8 neurostimulator, starting in Germany, now that the implantable device has a CE mark for the treatment of chronic back pain, the company announced May 25.

Mainstay Medical is ready to launch its ReActiv8 neurostimulator, starting in Germany, now that the implantable device has a CE mark for the treatment of chronic back pain, the company announced May 25.

Mainstay has its own direct sales force that will focus on German hospitals that treat a large back-pain patient population...

More from Archive

More from Medtech Insight

Planning To Take Part in MDUFA? FDA Wants To Hear From You

 

The US FDA needs to know who wants a seat at the MDUFA negotiations table before discussions can begin. The agency is asking stakeholders to let it know if they plan to participate in the periodic consultation meetings before July 28.

Global Medtech Guidance Tracker: June 2025

 
• By 

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 50 documents have been posted on the tracker since its last update.

Finland Cracks Down On Software That Needs Regulating As A Medical Devices

 

Finland has initiated a project to improve the effectiveness of the monitoring of software intended for medical use and to ensure that software placed on its market meets the requirements set for it.