AAMI Names Four New Members to Board of Directors
The new directors bring experience in HTM, medical device interoperability and cybersecurity, healthcare standards, and population health.
Tag: standards
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FDA Recognizes AAMI CR515 for AI- and ML-enabled Device Cybersecurity
The consensus report is now on FDA’s recognized standards list, giving manufacturers a clearer reference point and hospitals another document to ask about during purchase and support discussions.
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AAMI Announces Advisory Council and Location for 2026 neXus Conference
AAMI has named the advisory council and selected a venue for its 2026 medical device standards-focused conference.
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AAMI Names Four New Members to Board of Directors
The new directors bring experience in HTM, medical device interoperability and cybersecurity, healthcare standards, and population health.
FDA Issues Draft Guidance for AI-Enabled Devices
The FDA released draft guidance outlining a comprehensive framework for AI-enabled devices throughout their life cycle.
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AAMI Adds Ethylene Oxide to Materials Compatibility Guidance
AAMI has released TIR17:2024, updating guidance on ethylene oxide and new alternatives like chlorine dioxide and vaporized hydrogen peroxide.
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AdvaMed Lauds AI Task Force’s Call for Device Payment Pathway
AdvaMed applauds the House AI Task Force for calling on CMS to create payment pathways for AI-enabled devices.
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Kodiak Solutions Report Lists AI and Cybersecurity as Top Risks
Kodiak Solutions’ annual Top Risks list finds AI, cybersecurity threats, and regulatory compliance as key issues for health systems in 2025.
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ECRI Expands Total Systems Safety and HFE Solutions
ECRI has expanded its Total Systems Safety (TSS) and Human Factors Engineering (HFE) solutions to address preventable harm in healthcare.
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The Joint Commission and NAHQ Form Strategic Alliance
The Joint Commission and the National Association for Healthcare Quality have formed an alliance to advance global healthcare quality, focusing on quality competencies, professional certifications, co-developed training, and global best practices.
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FDA Updates Guidance on Third-Party 510(k) Review Program
The FDA issued updated guidance on the 510(k) Third Party Review Program and EUA Review, clarifying expectations, processes, and criteria.
