MAINSTAY MEDICAL INTERNATIONAL Mainstay Medical Holdings plc announced that the U.S. Food and Drug Administration (FDA) has approved full-body MRI conditional labeling for the ReActiv8® Restorative Neurostimulation system. This approval applies to all current and future ReActiv8 patients in the United States implanted with the current 45 cm commercially-available leads. The approval provides patients implanted with ReActiv8 the ability to undergo 1.5T full-body MRI scans.
Specific scan conditions and safety information are provided in the ReActiv8 FDA MRI Guidelines manual.
