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.
Category: Standards
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FDA Clears Abbott Dual-Energy Cardiac Ablation Catheter
The TactiFlex Duo combines pulsed field ablation and radiofrequency energy in a single catheter for treating patients with atrial fibrillation.
You Can’t Patch Everything, So Own the List That Decides What Gets Fixed First
Hospitals can’t address every medical device vulnerability at once, making clear ownership of the priority list—and HTM’s role in shaping it—critical.
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FDA Issues Early Alert for Becton Dickinson Convenience Kits
Certain procedure trays contain recalled sodium chloride ampules that may pose a risk of infection or organ failure.
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FDA Seeks Input on Generative AI Medical Device Regulation
The agency released a discussion paper to address the unique risks and potential of generative artificial intelligence in the healthcare ecosystem.
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Healthcare Leaders Report Network Security and Disruptions Impact Patient Care
A survey of more than 300 professionals indicates that cybersecurity is a top concern as technical teams struggle with system complexity.
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Securing the Biomedical Network: Building a Foundation for Safe, Connected Healthcare
A layered cybersecurity strategy can help healthcare organizations protect connected medical devices without disrupting clinical operations.
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IBM Report Finds AI-Enabled Data Breaches Cost Organizations Average of $6 Million
Malicious attacks using artificial intelligence increased 56% over the previous year, according to the 2026 Cost of a Data Breach Report.
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Baxter Identifies Cybersecurity Incident Involving Third-Party Applications
The company reports no impact on manufacturing, patient services, or medical technology safety.
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CHAI Forms New Group to Address Artificial Intelligence Cyber Threats
The work group will develop playbooks and risk assessment tools to help healthcare organizations defend against advanced model risks.
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HANYS Marketplace and ECRI Partner to Improve Patient Safety in New York Hospitals
The collaboration provides health systems with evidence-based solutions to address medical device safety, infection control, and medication practices.
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Joint Commission International Launches Clinical Certification Program
The certification provides a framework for specific service lines and does not require prior organizational accreditation.
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ECRI Names Cottage Health Winner of 2026 Health Technology Excellence Award
The nonprofit organization named the California health system the winner of its 2026 Health Technology Excellence Award for a program that redistributes blood products.
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Medline Recalls Neonatal Breathing Circuits Due to Thermal Damage Risk
The nationwide recall affects Hudson RCI neonatal and infant heated wire breathing circuits following reports of melting, smoke, and localized thermal damage at the humidifier connector.
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