FDA clears EBR Systems cybersecurity review with no recall
- The U.S. Food and Drug Administration completed its cybersecurity review of EBR Systems following a February incident.
- The regulator determined that no field corrective action or device recall is required for the WiSE System.
- EBR Systems is continuing product cybersecurity remediation and hardening activities through its regulatory processes.
EBR Systems (ASX:EBR) announced that the U.S. Food and Drug Administration completed a review of its cybersecurity assessment without ordering a device recall.
The regulatory update follows a cybersecurity incident that the medical device developer first detected in February and disclosed to the market on April 15.
“Following submission of EBR’s completed cybersecurity risk assessment, the FDA has advised that the incident aligns with a Controlled Risk classification and has agreed with EBR's response,” said EBR Systems President & CEO John McCutcheon.
The regulator advised that the event fits a controlled risk classification, and no evidence showed performance impacts on fielded devices.
The company confirmed its remediation work will include credential management updates, anti-phishing training, and enhanced endpoint monitoring.
Following the announcement, the EBR Systems share price was down at $0.29.
The medical firm develops wireless cardiac pacing technology designed to treat patients suffering from heart failure.
The business previously launched its WiSE Coupler accessory for commercial use in the United States during July.
