Tag: medical devices

A warning letter from the FDA to St. Jude Medical said the firm ignored warnings that its implantable medical devices and related software were vulnerable to hacking or unexpected failure.

Update: FDA says St. Jude Medical knew about Device Flaws 2 Years Before Muddy Waters Report

In-brief: In a damning report, the FDA said that St. Jude Medical* knew about serious security flaws in its implantable medical devices as early as 2014, but failed to address them with software updates or other mitigations, or by replacing those devices. (Editor’s note: updated to include a statement from Abbott and comment from Dr. Kevin Fu. – PFR April 14, 2017)