EBR Systems Says FDA Finds No Need for WiSE System Recall After Cybersecurity Incident

EBR Systems (ASX:EBR) said the US Food and Drug Administration (FDA) has completed its review of the company's cybersecurity risk assessment related to the February incident and determined that no field corrective action or recall of the WiSE System is warranted, according to a Wednesday filing with the Australian bourse.

The incident was classified as a controlled risk under FDA postmarket cybersecurity guidance, with no evidence of any impact on the safety or performance of fielded WiSE cardiac resynchronization therapy systems, per the filing.

The company continues its cybersecurity remediation efforts by strengthening credential controls, enhancing anti-phishing measures, expanding endpoint monitoring, hardening its products, and providing required updates to the FDA, the filing said.