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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After a hacker brought the issue to the attention of Smiths Medical, the company engaged US FDA and the Department of Homeland Security, which alerted users that Smith's Medfusion 4000 wireless syringe infusion pumps are at risk from multiple cybersecurity vulnerabilities.
Following months of bickering between St. Jude and Muddy Waters Research, US FDA issued a safety alert for the device-maker's wireless cardiac devices. The agency says there's a risk for malicious cyber-attacks and recommends a software patch to minimize risk.
Top lawmakers on the House Energy and Commerce Committee wrote to US FDA asking what the agency is doing to ensure devices are protected against malicious hackers.