A blog about what is new (and old) in the world of active implantable medical devices 

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Pacemaker Hacking Hysteria and Conspiracies

I’ve been receiving tons of e-mail today from well-meaning friends to tell me about a major story in the news: “Hacker Found Dead Before Revealing Pacemaker Hacking Secrets” Actually, the major news outlets just picked up the story.  Ethical hacker Barnaby Jack was found dead on July 25, 2013. In any case, the media is

 
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FDA Publishes Draft Guidance on Medical Device Cybersecurity

FDA has published a draft of the guidance document that it has developed to assist industry by identifying issues related to cybersecurity that manufacturers should consider in preparing premarket submissions for medical devices.  This guidance document is intended to supplement FDA’s “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices” and

 
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