Australia's Therapeutic Goods Administration asked for additional clinical data on Mainstay Medical's ReActiv8 neurostimulation device for chronic low-back pain, so the company will provide clinical data from the ongoing ReActiv8 B trial.
Mainstay Medical's ReActiv8 neurostimulator for chronic low-back pain • Source: Mainstay Medical
Data from the US ReActiv8 B trial of Mainstay Medical International PLC's ReActiv8 neurostimulator to treat low-back pain will supplement the company's regulatory application in Australia.
The Irish company announced on April 5 that Australia's Therapeutic Goods Administration has requested additional clinical data supporting the regulatory...
