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22nd September 2022

FDA issues alert on Medtronic insulin pump security

Medtronic issued an urgent warning to alert consumers to this risk and offer advice.

The U.S. Food and Drug Administration issued a warning on Tuesday regarding the vulnerability of some insulin pump devices made by Medtronic (MDT.N) to cyberattacks and the possibility that hackers could interfere with insulin delivery by gaining access to the device.

Dr. Suzanne Schwartz,
Dr. Suzanne Schwartz, FDA’s deputy director of the Office of Strategic Partnerships and Technology Innovation.

The FDA stated that up to this point, it was not aware of any reports pertaining to this cybersecurity weakness, which may allow an unauthorised individual to access a pump while it was coupling with other system parts.

The insulin pumps are offered through Medtronic’s diabetes division, which generated $2.41 billion in sales in 2021, or 8% of the company’s overall revenue.

In order to alert consumers to this risk and offer advice, Medtronic issued an urgent warning. To detect, explain, and stop this cybersecurity issue from happening, the corporation is collaborating with the FDA.

“The FDA urges manufacturers everywhere to remain vigilant about their medical products – to monitor and assess cybersecurity vulnerability risk, and to be proactive about disclosing vulnerabilities and mitigations to address them,” FDA deputy director of the Office of Strategic Partnerships and Technology Innovation, Dr. Suzanne Schwartz, released in a statement.

“Any medical device connected to a communications network, like Wi-Fi, or public or home Internet, may have cybersecurity vulnerabilities that could be exploited by unauthorized users,” said Schwartz.

“However, at the same time, it’s important to remember that the increased use of wireless technology and software in medical devices can also offer safer, more convenient, and timely health care delivery.”

Medtronic is “providing alternative insulin pumps to patients with enhanced built-in cybersecurity capabilities,” said the FDA alert.


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