FDA Finalizes Medical Device Cybersecurity Premarket Guidance
The FDA has finalized guidance to assist medical device sponsors in addressing cybersecurity considerations as part of the premarket review process.
The FDA has finalized guidance to assist medical device sponsors in addressing cybersecurity considerations as part of the premarket review process.
Lawmakers and experts warned that aging and outdated medical devices pose growing cybersecurity risks that could impact both patient safety and national security.
KomodoSec aided a life-support device maker in overcoming cybersecurity and regulatory hurdles to achieve FDA 510(k) approval.
The FDA has finalized guidance to assist medical device sponsors in addressing cybersecurity considerations as part of the premarket review process.
Mindray North America has achieved UL 2900-2-1 certification for its BeneVision N12, N15, and N17 patient monitors.
Read MoreImproving medical device security requires real-time monitoring and comprehensive visibility of hardware and firmware, according to two industry experts. They explain their reasoning here.
Read MoreClaroty research revealed that 13% of mission-critical operational technology (OT) assets have insecure internet connections.
Read MoreMedISAO, dedicated to improving medical device security, announced its renewed Memorandum of Understanding (MOU) with the FDA.
Read MoreHow HTMs can help secure facilities from cyberattacks via specialized training, asset management, prioritization, and response planning.
Read MoreThe Exploit Prediction Scoring System (EPSS) helps prioritize cybersecurity threats by assessing their likelihood of exploitation, allowing teams to focus on the most significant risks. Asimily CEO Shankar Somasundaram explores this topic further.
Read MoreThe FDA now mandates that medical device manufacturers include a Software Bill of Materials for cybersecurity compliance under the FD&C Act.