Fresenius Kabi Issues Critical Software Update for Ivenix Infusion Pumps
FDA identifies Class I recall as most serious type due to software anomalies that may cause unexpected shutdowns and interface freezing.
Category: Standards
Standards
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Standards
Latest
FDA Clears Mobile C-Arm System With AI-Enhanced Imaging
The mobile C-arm system features AI-powered imaging tools and cable-free design for interventional procedures.
Standards
Latest
Coalition Urges HHS to Withdraw Proposed HIPAA Security Rule
More than 100 healthcare organizations are calling on HHS to withdraw the proposed HIPAA Security Rule update and pursue a collaborative approach to cybersecurity standards.
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FDA Clears for Augmented Reality Navigation Platform for Neurosurgery
The system is designed to give surgeons a clear, real-time view of critical anatomy and planned trajectories.Â
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FDA to Accept De-identified Data for Certain Medical Devices Submissions
New guidance permits the use of de-identified data without requiring individual patient information in marketing submissions.Â
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Survey Reveals Disconnect Between Hospital Cybersecurity Goals and IoMT Device Risk Management Practices
43% of hospital security leaders name IoMT visibility as their top cybersecurity challenge, while internal process issues create the biggest obstacle to effective risk management.
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Advocacy Group Renews Push for Medical Right to Repair
US PIRG is surveying HTM professionals to document how repair restrictions affect patient care, downtime, and costs.
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What HTM Needs to Know About The Joint Commission’s New Accreditation Model
As Accreditation 360 rolls out in January 2026, the Joint Commission explains what’s changing, what isn’t, and how HTM teams can prepare.
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GE HeathCare Recalls Carestation Anesthesia Systems Due to Shutdown Risk
GE HealthCare is updating use instructions after reports certain systems may not switch to battery mode during AC power loss, potentially disrupting ventilation and agent delivery.
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HSCC’s AI Cyber Guidance Is a Map. HTM Pros Are the Guides (Editor’s Message)
New AI cybersecurity guidance is set to roll out in early 2026, as AI becomes more embedded in healthcare technology.
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Congress Removes Military Right to Repair Provisions from Defense Bill
Bipartisan provisions that would have expanded military access to repair data and technical information were removed from the final FY26 defense authorization bill.
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FDA Launches Digital Health Pilot for Chronic Disease Technologies
The pilot will evaluate a new, risk-based enforcement approach that supports digital health devices intended for use in chronic conditions.
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Baxter Permanently Removes Life2000 Ventilation System Due to Cybersecurity Issue
The company is pulling the Life2000 system from the market after finding a vulnerability that could allow unauthorized changes to ventilation settings.
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NOxBOXi Delivery System Correction Issued After Reports of Nitric Oxide Dose Fluctuations
The FDA issued a safety alert after users reported nitric oxide dose fluctuations, potentially leading to hypoxemia or increased pulmonary artery pressure.Â
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