Pacemaker patch passes probe by Food and Drug Administration

Pacemaker patch passes probe by Food and Drug Administration

This access could be used to modify programming commands to the implanted pacemaker, which could result in patient harm from rapid battery depletion or administration of inappropriate pacing.

RECOMMENDATIONS: The firmware update requires an in-person patient visit with a health care provider - it can not be done from home via Merlin.net.

The St. Jude Medical pacemaker flaws that an investor relied on to short the company's stock has a new patch to address the issue.

"Because all networked medical devices are potentially vulnerable to cybersecurity threats, the FDA has been working diligently with device manufacturers and other stakeholders to ensure the benefits of medical devices to patients continue to outweigh any potential cybersecurity risks", he said in a release, calling for "multi-stakeholder engagement" in managing medical device cybersecurity risks. In some cases, the risks may necessitate the performance of the procedure at a facility with a temporary pacemaker generator. The agency said there are 465,000 impacted devices in the USA, but noted the update does not require prophylactic removal and replacement.

"These are part of planned updates we mentioned back in January, and further strengthen the security and device management tools for our connected cardiac rhythm management (CRM) devices", Steele Flippin said of this week's pacemaker update.

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The US Food and Drug Administration said it had approved the new firmware update after reviewing and confirming claims that hackers could exploit vulnerabilities in St. Jude's radio frequency-enabled heart implants to reprogram them to pace at unsafe rates or drain their batteries. But the FDA has confirmed that Muddy Waters did not notify the agency until after the firm publicly released its findings (see Report on Cardiac Device Cyber Vulnerabilities Fuels Debate). The recall applied to devices implanted in the US, Canada, and Australia.

"These vulnerabilities, if exploited, could allow an unauthorized user (i.e. someone other than the patient's physician) to access a patient's device using commercially available equipment". The Merlin Programmer and Merlin@home Transmitter will provide the authorization.

The update is for pacemakers with radio frequency (RF) telemetry capabilities, meaning that they are wirelessly connected by radio waves for recording and transmitting the readings of the devices. Those claims launched a testy legal battle between the investment firm and St. Jude Medical.

Now, 12 months after Muddy Waters published the report, Abbott has identified and fixed another cybersecurity vulnerability.

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