The agreement will focus on delivering integrated solutions to support device cybersecurity, interoperability, and regulatory compliance from development through deployment.
The probe will examine how dependence on foreign-made medical devices and supplies—including imaging systems, ventilators, consumables, and PPE—could pose national security risks.
A new cybersecurity report finds few companies are prepared for the EU’s Cyber Resilience Act, which will require software component lists for connected devices.
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The guidance promotes the use of a Software Bill of Materials to increase transparency in the software supply chain, impacting medical device security and vulnerability management.
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Why HTM teams must treat “old but working” as a high-stakes cyber risk—and how to protect patients and operations now.
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New Sedgwick report shows Q2 2025 saw highest quarterly Class I medical device recalls in two decades, while agency launches generative AI tool for faster approvals.
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The updated voluntary guidance reflects the evolution of SBOM practices and aims to help organizations better manage software supply chain risks.
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The proposed legislation would require manufacturers to provide parts, documentation, and tools, following similar laws passed in four states.
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The devices may have cracks that could lead to patient rebreathing of exhaled gases.
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The most serious type of recall was initiated due to a blocked manometer port, which can prevent pressure monitoring and lead to severe patient harm.
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A software flaw that may cause the Plum Duo Infusion System to become unresponsive has prompted a device correction, which the FDA has identified as its most serious recall type.
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The FDA has issued a Class I recall designation for the correction, which addresses a fault that can cause ventilation to stop unexpectedly.
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The medtech association cites risks to patient safety, reduced competition, and potential cost increases if the rule is implemented as is.
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The permanent injunction prohibits Biosense Webster from using ‘kill switches’ and tying clinical support to new device purchases, a practice the court found blocked hospital access to lower-cost reprocessed cardiac catheters.
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