Archimedes Center

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

In-brief: The FDA as approved a software update to software security holes in pacemakers made by Abbott. But doctors and patients will have to weigh the risks of apply the patch. 

It’s the Risk, Stupid: FDA Medical Device Guidance Looks Past the Device

In-brief: The FDA’s final guidance on cybersecurity for postmarket medical devicesmarks a departure from earlier drafts, focusing generically on cybersecurity risk management and jettisoning an early focus on the threat posed by “connected devices” that some considered too narrow.

The Big Short: Alleged Security Flaws Fuel Bet Against St. Jude Medical

In-brief: The stock of medical device maker St. Jude plunged by 5% on Thursday after a report called for investors to bet against (or “short”) the company’s stock over serious security vulnerabilities in a range of the company’s implantable cardiac devices.