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Medical Devices / Regulatory Affairs

FDA Cautions on Cybersecurity Vulnerabilities in Medical Devices

Oct. 3, 2019

The FDA has issued a warning on vulnerabilities in several operating systems that could impact network-connected medical devices and put patients at risk.

The vulnerabilities, called “URGENT/11” by the agency, are found in third-party software, IPnet, that is used by computers to connect with each other over a network. The FDA said that several operating systems, in addition to various software and equipment, currently use the exploitable technology.

Remote users could potentially exploit the cybersecurity vulnerabilities to gain control of medical devices and leak information, change functions or cause other damage that may result in a device ceasing to function properly or at all, the agency said.

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