Heartburn: Yet Another Device-Maker Is Facing Cardiac Device Cybersecurity Worries – This Time, It's Medtronic
Medtronic cardiac devices are vulnerable to malicious hackers who could potentially not only intercept data between the patient and their provider, but also may be able to manipulate the implantable cardiac devices, possibly leading to serious adverse events and death. US FDA says patients should continue to use the devices as usual but should look out for telltale signs of an attack. Meanwhile, Medtronic claims it was aware of the issue and contends that patients shouldn't be concerned: “To date, no cyberattack, privacy breach, or patient harm has been observed," a spokesman says.
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The FDA is convening a panel of experts in September to talk about how to craft cybersecurity communications that adequately alert patients about potential vulnerabilities while not creating a panic. The meeting comes as the agency has been putting out a growing number of cybersecurity alerts, including most recently a recall for certain vulnerable Medtronic insulin pumps.
After Abbott recently settled a case against short-seller Muddy Waters, the company has put out a second cybersecurity patch for certain St. Jude radio-frequency enabled cardiac devices to stop potential hackers from harming patients.
The tools include new laboratory methods, and computational models and simulations give the agency more capabilities to test and validate data in premarket submissions.