Sen. Tom Cotton (R-AR) is urging the Food and Drug Administration (FDA) to crack down on Chinese-made medical devices, asking for an extensive review to protect Americans and their information.
Cotton, who is Chairman of the Senate Intelligence Committee, sent a letter to Acting FDA Commissioner Kyle Diamantas, expressing concerns over what he described as “cybersecurity vulnerabilities associated with networked medical devices manufactured in China.” The use of these devices poses a risk, the senator said, to not only national security but also public health. He pointed to the FDA and Cybersecurity and Infrastructure Security Agency’s (CISA) warning last year, which cautioned of “cybersecurity vulnerabilities associated with the Contee CMS8000, a networked patient monitoring device manufactured in Communist China.”
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According to the FDA’s findings, the CCP-made medical device would actually “automatically extract personally identifiable patient health information when connected to the Internet. This, he continued, can lead to a myriad of problems — from identity theft to “sophisticated scams against American patients.”
Further, CISA found that this Chinese medical device was also programmed to allow “unverified users to remotely control the device without a health provider’s knowledge.”
Cotton wrote in the May 26 letter, “This gave malign Chinese actors an opportunity to directly manipulate how the device operates and displays data, potentially leading to dangerous misdiagnoses of heart failure, arrhythmias, and hypertension.”
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As a result, the FDA issued a Class II recall of the device on May 14, 2025, and began requiring manufacturers of such devices to “demonstrate enhanced cybersecurity safeguards to receive FDA pre-market clearance in 2023.” However, the requirement did not extend to devices before 2023. Cotton believes something must be done about that, asking both the FDA and CISA to review CCP-made devices that were cleared before March 29, 2023.
“Chinese medical devices open the door for the CCP to access sensitive health data,” Chad Wolf, former Acting Secretary of Homeland Security, said in an exclusive statement obtained by Breitbart News.
“Senator Tom Cotton is protecting American patients and stopping the threat of Communist China in our hospitals,” he said. “It’s important for the FDA to continue cracking down on Chinese medical devices in U.S. hospitals and close the data backdoor because patient privacy and national security are non-negotiable.”
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Individual states are also taking action. In March, Texas Gov. Greg Abbott (R) sent a letter to state agencies, asking for a review of cybersecurity concerns linked to Chinese-manufactured medical equipment.
“I will not let Communist China spy on Texans,” Abbott said. “State-owned medical facilities must ensure there are safeguards in place to protect Texans’ private medical data.”
Florida Attorney General James Uthmeier took similar action earlier this year as well.
“Today, we sent a letter to Mindray North America demanding an audit and disclosure of the company’s ties to the Chinese Communist Party,” he wrote. “As part of our office’s proactive efforts to protect Floridians’ personal information, we will also be demanding audits from United Imaging, MicroPort, Edan Instruments, Lepu Medical Tech, Shinva Medical Instruments, Neusoft Medical Systems, Longest Medical, and Jiangsu Yuyue Medical.”
This coincides with the United States Office of Management and Budget recently proposing a rule revision that would block grant funding for applicants if they are affiliated with groups that “undermine public safety or national security” of the United States.
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