FDA Recommends Security Patch For St. Jude Wireless Cardiac Devices
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.
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St. Jude appears to still be pursuing legal action against Muddy Waters, despite an FDA alert that seems to vindicate the short-seller's discovery of cybersecurity vulnerabilities with the device-maker's wireless implantable cardiac products.
FDA investigators are concerned Abbott's St. Jude Medical subsidiary failed to adequately address concerns over cybersecurity vulnerabilities and premature battery drain on their cardiac devices manufactured at its Sylmar, Calif., facility.
The digital medtech sector is growing fast. As new companies enter the space, they are going to face oversight from a slew of government agencies and statutes. While FDA is an important focus for medtech, patient privacy and cybersecurity challenges for digital products raise other, significant compliance challenges. Medtech Insight discussed the range of hurdles the digital medtech industry faces with attorneys from Akin Gump.