Home/Incidents/EBR Systems, Inc.

EBR Systems, Inc.

9 Sep 2026 · International · Healthcare
Unauthorised Access UNKNOWN ✓ Verified

What happened

Medical device developer EBR Systems provided an official update regarding a cybersecurity incident first identified in February 2026 and disclosed to the ASX on 15 April 2026. Following the submission of a comprehensive cybersecurity risk assessment completed with third-party forensic specialists, the US Food and Drug Administration (FDA) reviewed the findings and confirmed that no field corrective action or device recall was warranted for its WiSE CRT System. The FDA classified the event as a Controlled Risk under its postmarket cybersecurity guidance. EBR confirmed no evidence was found indicating any impact on the safety, integrity, or operational performance of fielded devices. Response measures included credential hardening, anti-phishing training, enhanced endpoint monitoring, and ongoing product security remediation.

Incident details

Organisation
EBR Systems, Inc.
Date
9 Sep 2026
Attack type
Unauthorised Access
Severity
UNKNOWN
Sector
Healthcare
State
International
Records affected
Unknown
Threat actor
Unknown

Source

marketindex.com.au ↗
← Back to all incidents