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St. Jude Hacking-Risk Allegations: US FDA Continues Assessment, As Firm Files Lawsuit

While conflicting reports have surfaced regarding the veracity of allegations from a short-seller that a significant number of St. Jude cardiac rhythm management devices have serious cybersecurity flaws, FDA says plans to complete an initial assessment of the allegations soon. The Minnesota device-maker, meanwhile, says it is suing the short-seller for disseminating false information.

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[Editor's note: This article has been updated to clarify that FDA plans to complete an initial internal assessment of the Muddy Waters' allegations in the coming weeks, and that the agency will communicate findings publicly if warranted. The article has also been updated to state that ICS-CERT, not FDA, assigns case tags when warranted and that the 30-day clock for manufacturers to conduct an initial assessment of potential cybersecurity vulnerabilities is a draft guidance proposal, not a requirement.]

US FDA says it continues to investigate allegations by investment research firm that St. Jude Medical Inc. cardiac devices...

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