While new cybersecurity guidance from the Food and Drug Administration recognizes the responsibility for keeping medical device data secure is shared among stakeholders, it also offers several steps ...

Ransomware attacks on healthcare facility networks are causing medical device "outages" that put patient lives at risk, according to Kevin Fu, acting director of cybersecurity at the FDA's Center for ...

Blue Goat Cyber leads medical device cybersecurity compliance, helping manufacturers meet the FDA’s finalized cybersecurity guidance issued June 27, 2025. We help medical device manufacturers not just ...

On October 1, 2024, the Food and Drug Administration (FDA) marked a major milestone in medical device cybersecurity enforcement. This marks one year since the retracted Refuse to Accept (RTA) policy ...

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In June 2025, the US Food and Drug Administration (FDA) issued a final guidance titled Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions (2025 ...

As cybersecurity threats have become more and more pressing in the healthcare industry in the last several years, FDA has taken several steps to strengthen the security of medical devices seeking ...

Tuesday's house hearing on medical device cybersecurity included discussions on how hospitals and other providers can keep up with cyber threats as well as what the effect of Tuesday's massive layoffs ...

The FDA’s cybersecurity bill of materials has major implications – both good and bad – for healthcare provider organizations’ IT and security teams. While it may seem like a no-brainer to allow ...

Jan. 20-21 the Food and Drug Administration will host the “Moving Forward: Collaborative Approaches to Medical Device Cybersecurity” public workshop to bring stakeholders together for discussion on ...