The FDA issued a Warning Letter to WAVi following a 2023 inspection regarding the regulatory status of certain research-oriented software tools associated with the WAVi EEG platform.

Following receipt of the Warning Letter, WAVi implemented corrective actions in response to the agency’s observations. The FDA has now issued a close-out letter confirming that it has completed its evaluation of these corrective actions and that the matters identified in the Warning Letter have been addressed.

A close-out letter indicates that the FDA considers the specific issues cited in the Warning Letter to be resolved, subject to ongoing regulatory oversight consistent with standard agency practice.

WAVi remains committed to maintaining robust quality systems, responsible communication, and compliance with applicable regulatory requirements. We will continue to support clinicians, researchers, and partners with technology developed and managed under these standards.

For questions regarding WAVi’s regulatory status, please contact info@wavimed.com or visit our website at wavimed.com.

—
The WAVi Team