AAMI Backs Expanded Use of Consensus Standards Under MDUFA VI
The association says FDA’s proposed approach could strengthen the role of consensus standards in medical device regulation, maintenance, and international harmonization.
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CMS Awards $50 Billion to States to Support Rural Health Infrastructure and Technology
The Rural Health Transformation Program will fund facility modernization, technology upgrades, and workforce initiatives across all 50 states beginning in 2026.
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Reprocessed ‘Single-Use’ Medical Devices Help Hospitals Save $451M in 2024
A new survey shows that hospitals saved over $451 million and cut 115 million pounds of CO₂ by using regulated, reprocessed 'single-use' medical devices.
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AAMI Backs Expanded Use of Consensus Standards Under MDUFA VI
The association says FDA’s proposed approach could strengthen the role of consensus standards in medical device regulation, maintenance, and international harmonization.
FDA Adds AAMI Sterilization Guidance to Standards Database
FDA has recognized four AAMI sterilization documents in its Consensus Standards Database, including updated guidance on ethylene oxide usage.
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NFPA Proposes Reorganized National Electrical Code
NFPA is seeking industry feedback on reorganizing the 2029 National Electrical Code to address evolving technologies and terminology.
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AI Risks Tied to Technology Type and Healthcare Context
Paragon Health Institute’s new report urges context-specific AI regulation in healthcare, leveraging existing agencies, avoiding centralization, and balancing innovation with safety to protect public interests.
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Quest Expands Field Corrective Action Services for OEMs
Quest International has expanded its FCA services, offering medical device OEMs scalable solutions for regulatory compliance.
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ISS Solutions Achieves ISO 13485:2016 Certification
ISS Solutions has obtained ISO 13485:2016 certification, confirming its adherence to quality management standards for medical devices and ensuring their safety and reliability.
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ASHE Announces 2025 Advisory Board Election Results
ASHE announced the results of its 2025 Advisory Board election, appointing Dennis Ford as president-elect and several regional reps.
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AAMI Releases New Guidance for Radiation Sterilization
AAMI released new guidance to update best practices for radiation sterilization validation and routine control of single-use systems.
