The U.S. Food and Drug Administration (FDA) is considering revising its standards for certifying medical devices to require older technology to undergo a cybersecurity clearance similar to that used for new devices. This move aims to protect Americans from compromised medical devices, which could pose risks to both national security and public health.
The FDA is planning to revise its standards for certifying medical devices by requiring older technology to undergo a cybersecurity clearance similar to that used for new devices.
The agency began requiring medical devices to demonstrate enhanced cybersecurity safeguards to receive FDA premarket clearance in March 2023, but older devices still on the market do not require the same type of testing. Cotton said in the letter that more must be done to protect Americans from compromised medical devices. He also mentioned that a popular medical monitor that tracks patients' vital signs would automatically extract patients' personally identifiable health information when connected to the internet.
Additionally, the device was programmed to allow unverified users to remotely control the device, potentially leading to dangerous misdiagnoses of heart failure, arrhythmias, and hypertension. According to FDA records, roughly 7,000 monitors were recalled. They still remain in use in some hospitals, however, in part because there is no record of how many are in use nationwide.
A sizable percentage of U.S. hospitals depend on Chinese-made equipment, ranging from basic medical supplies such as syringes and gloves to computerized monitoring systems such as the recalled Contec CMS8000. On the whole, 14% of all medical equipment in U.S. hospitals and more than 50% of basic medical supplies are made in China, according to a 2025 analysis of industry data from the journal $84.55 billion worldwide Hospital diagnosis and treatment equipment, the largest category of China's medical device exports, was valued at $22.26 billion in 2024
FDA Medical Devices Cybersecurity Certification Older Technology Recalled Monitors Chinese-Made Equipment Hospitals Medical Supplies Computerized Monitoring Systems
United States Latest News, United States Headlines
Similar News:You can also read news stories similar to this one that we have collected from other news sources.
Donald Trump's Talks with Muslim Leaders About Ending Iran WarSpark Plans for Broader Peace PlansA recent report revealed that the President asked several Middle Eastern countries to enter peace agreements with Israel by signing onto the Abraham Accords, a historic agreement that could potentially normalize relationships between Arab states and Israel if confirmed by multiple Arab countries said to be on the line with Trump when he made his reported request for them to sign onto the Abraham Accords. The main goal of the Abraham Accords is to broker a peace agreement between Saudi Arabia and Israel while US President Donald Trump reportedly asked multiple Arab countries during a phone call Saturday to sign peace agreements with Israel if an deal is struck to end the Iran war.
Read more »
Pope Leo XIV Demands Global AI Regulation and Ethical Standards in Groundbreaking ManifestoThe Pope calls for worldwide, binding rules on artificial intelligence, urging developers to prioritize the common good over profit and proposing a Digital Geneva Convention to oversee AI's impact on society and warfare.
Read more »
ICE responds to NJ Democrats' claims on detainee treatment: 'Higher detention standards'U.S. Immigration and Customs Enforcement on Tuesday responded to New Jersey Democrats' claims about the allegedly poor treatment of detainees in ICE facilities.
Read more »
Warnings issued to Alabama doctors against non-FDA-approved peptides amid social media popularityThe Alabama State Board of Medical Examiners has issued an alert to physicians and other medical professionals across Alabama.
Read more »