At WAVi, our mission is to bring objective EEG and ERP data into clinical and research settings in a manner that is scientifically grounded, clinically useful, and fully compliant with FDA regulations. As part of this commitment, we want to share an update on recent regulatory matters, including our response to an FDA Warning Letter and the steps we’ve taken since.

Background: The FDA Warning Letter

In October 2023, WAVi received a Warning Letter from the U.S. Food and Drug Administration (FDA) regarding certain aspects of our marketing, software distribution, and quality system practices. Specifically, the FDA raised concerns about:

• Promotional language that may have suggested diagnostic uses not aligned with the cleared intended use.

• Distribution of non-cleared research software without appropriate validation or regulatory exemption.

• Quality system procedures, documentation, and internal auditing gaps.

We took these findings seriously and immediately initiated a comprehensive response and remediation process.

What We’ve Done Since

1. Recalled Research Software & Materials

We voluntarily discontinued all distribution of our legacy “WAVi Desktop” research software and associated documentation. We formally notified all users and have removed references from our website, training, and social platforms. We now exclusively distribute the FDA-cleared WAVi™ SCAN system.

2. Re-aligned All Marketing with FDA-Cleared Intended Use

WAVi SCAN is cleared for the acquisition, display, and storage of EEG and ERP data to aid in diagnosis. We have conducted a full review and revision of all marketing language to ensure:

• No diagnostic or treatment claims beyond what is cleared.

• No promotional descriptions implying performance in evaluating specific conditions.

• Testimonials and content are consistent with the device’s cleared function as a data collection tool.

3. Implemented a New Quality Management System (QMS)

Following additional FDA Form 483 observations from a recent inspection, we’ve taken major steps to overhaul our QMS:

• Hired a dedicated Quality Control Manager.

• Developed and validated new procedures covering software validation, manufacturing documentation, and internal audits.

• Created and executed Corrective and Preventive Actions (CAPAs) for every FDA finding.

• Validated our EPU (electrical processing unit) and updated design records to align with current practices.

4. Ongoing Engagement with FDA

We are maintaining regular communication with the FDA, including formal updates, written responses, and a recent meeting request to clarify marketing expectations and ensure lasting compliance. Our team has provided comparative claim analyses, reviewed predicate language from similar 510(k)-cleared devices, and sought feedback on permissible descriptions.

Where We Stand Now

• Only the WAVi™ SCAN system is currently in distribution, consistent with 510(k) K213900.

• WAVi has fully withdrawn its research-use platform from commercial use.

• We are committed to transparency, quality, and continuous improvement as we move forward.

Open Dialogue

We believe that transparency builds trust—with regulators, clinicians, and the communities we serve. We will continue to provide updates as we complete our corrective actions and further enhance our QMS.

For questions about our current device, regulatory status, or marketing claims, please contact us directly at info@wavimed.com.

Thank you for your continued support as we continue to evolve with integrity and purpose.

—
The WAVi Team