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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.

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House Subcommittee Holds Hearing on Cybersecurity Risks in Legacy Medical Devices

Lawmakers and experts warned that aging and outdated medical devices pose growing cybersecurity risks that could impact both patient safety and national security.

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KomodoSec Offers Cybersecurity Guidance for FDA Clearance

KomodoSec aided a life-support device maker in overcoming cybersecurity and regulatory hurdles to achieve FDA 510(k) approval.

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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.

BeneVision Patient Monitors Earn Cybersecurity Certification

Jun 4, 2024

Mindray North America has achieved UL 2900-2-1 certification for its BeneVision N12, N15, and N17 patient monitors.

Why Medical Devices Require a New Definition of Security

May 23, 2024

Improving medical device security requires real-time monitoring and comprehensive visibility of hardware and firmware, according to two industry experts. They explain their reasoning here.

Claroty Finds 13% of Critical OT Vulnerable to Exploits

May 21, 2024

Claroty research revealed that 13% of mission-critical operational technology (OT) assets have insecure internet connections.

FDA Endorses MedISAO for Medical Device Security Efforts

May 20, 2024

MedISAO, dedicated to improving medical device security, announced its renewed Memorandum of Understanding (MOU) with the FDA.

HTM’s Vital Role in Medical Equipment Cybersecurity

May 9, 2024

How HTMs can help secure facilities from cyberattacks via specialized training, asset management, prioritization, and response planning.

What’s the Role of the EPSS in Prioritizing Security Threats?

May 6, 2024

The 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.