A Year Later: FDA approves Software Fix for Security Flaws in Pacemakers

The FDA has approved a firmware update to address security vulnerabilities in several Abbott/St. Jude implantable cardiac devices after researchers (MedSec) disclosed exploitable flaws — including a hardcoded universal unlock code — that could allow unauthorized users to modify pacemaker programming and potentially harm patients; Abbott issued a patch, the FDA found the company had been aware of issues since 2014, and patients must visit clinicians to receive a brief firmware update while weighing risks and benefits.