Saluda Medical receives US FDA approval for Evoke System MRI labelling
Saluda Medical, Inc., a global medical device company, announced that the US Food and Drug Administration (FDA) has approved MRI conditional labelling for the Evoke System, the first and only precision, dose-control spinal cord stimulation (SCS) therapy powered by SmartLoop technology. This approval applies to all commercially implanted Evoke System patients in the United States as well as patients formerly enrolled in the ECAP Study.
