The FDA Wants to Know if St. Jude Medical Devices are Safe

It is the latest in the unfolding story involving medical device manufacturer St. Jude Medical, activist investment-research firm Muddy Waters, and cybersecurity firm MedSec Holdings: FDA plans a “thorough investigation” of allegations Muddy Waters and MedSec have made about security vulnerabilities in St. Jude’s cardiac devices.

“Regardless of the way a vulnerability comes to our attention, we take those allegations very, very seriously,” Suzanne Schwartz, FDA's official responsible for cybersecurity, recently told Reuters. “We are putting all of our focus on making sure that we have an understanding of what these allegations are and do a thorough investigation of the claims.”

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