Pacemaker patched... one year after critical flaws reported

St. Jude pacemakers

This recall is the most serious development so far related to medical device cybersecurity, Corman contends.

The FDA confirmed the vulnerabilities months later and issued a warning letter to Abbott in April after the pharmaceutical giant acquired St. Jude Medical.

St. Jude patched the products after short-seller Muddy Waters Capital outlined the vulnerability in a report.

It marks the first time the FDA has issued a recall for cybersecurity concerns. The alert does not apply to any implantable cardiac defibrillators or to cardiac resynchronization ICDs, the FDA says.

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The FDA prohibited the distribution and sale of small turtles - those with shells four inches and smaller - in 1975. Turtles carry salmonella bacteria on their shell and skin, which does not affect them but transmits to humans.

"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".

Abbott Laboratories (NYSE:ABT) has released a new set of software updates created to protect hundreds of thousands of pacemakers from hacking.

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.

According to the FDA, "the update process will take approximately 3 minutes to complete".

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"If we do find them, we could look at it as a reason not trust the devices, or we could look at it like we're going from a mode of silent failures to one where we're starting the process to inform smarter and better designs", Corman said.

Patients' devices will be updated with the new battery alert automatically.

There is a low risk of an update malfunction. The FDA and Abbott do not recommend the removal and replacement of affected pacemakers and suggest that the risks of cybersecurity be discussed between patients and their providers. Based on Abbott's data, there's a 0.161 percent chance the update reloads old firmware due to an incomplete update; a 0.023 percent chance that the update will wipe programmed device settings; a not reported chance of loss of diagnostic data; and a 0.003 percent chance the device becomes bricked.

For pacing dependent patients, consider performing the cybersecurity firmware update in a facility where temporary pacing and pacemaker generator can be readily provided.

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The biggest factor that caused the halt is because an already slow August witnessed no major new releases last weekend. The film became the highest-grossing superhero origin movie ever made last week, likely sparking its second wind.

In a Tuesday statement, Abbott notes: "There have been no reports of unauthorized access to any patient's implanted device, and according to an advisory issued by the U.S. Department of Homeland Security, compromising the security of these devices would require a highly complex set of circumstances".

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