Mainstay Medical Obtains European and Australian Approvals for MRI Compatibility of ReActiv8® Restorative Neurostimulation System™

Wednesday, July 10, 2024

Mainstay Medical Holdings plc has announced it has received regulatory approvals in the European Union, the United Kingdom, and Australia for the conditional whole-body MRI labeling of the ReActiv8® Restorative Neurostimulation System.

This allows all current and future ReActiv8 patients in Europe and Australia with the commercially available 45 cm electrodes to undergo 1.5T whole-body MRI scans.

The ReActiv8 MRI Guidelines Manuals for each region will provide specific scanning conditions and safety information.

These MRI approvals were granted alongside certificates from the company's notified body, confirming compliance with the Medical Device Regulations (MDR) of the European Union and the United Kingdom.

"These MRI approvals enable us to broaden access to ReActiv8 for patients in Europe and Australia who need MRI imaging after implantation."

This complements our previous MRI label approval in the United States. We also take pride in our dedication to patient safety and product quality, as shown by being among the first in the neuromodulation space to achieve MDR certification for Europe and the UK.

Next week, customer information emails will be sent out, and the MRI guidelines and related information will be made available.