FDA Issues Recall Early Alert for Olympus Single-Use Ligating Devices
Olympus has updated use instructions after reports that the ligation loop may not release as expected, potentially requiring emergency intervention.
Category: Standards
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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.
FDA Clears AI Tool for Coronary Plaque Analysis
The clearance enables on-premise AI analysis of coronary CT angiography for quantifying calcified and non-calcified plaque.
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How Technology Will Drive the $50 Billion Rural Health Transformation
A new federal program aims to modernize rural healthcare, with technology managers and digital tools playing a central role in its success.
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FDA Clears YorLabs Intracardiac Imaging System
The no-capital-expenditure ultrasound platform is designed to simplify workflow, reduce cost, and enhance procedural efficiency inside the cath lab.
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Health Sector Publishes Systemic Risk Mapping Toolkit
The new resource by the sector for the sector guides healthcare organizations to track and manage critical third-party services that support essential workflows.
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ECRI Experts Spotlight AI Risks, Human Factors, and Maternal Safety at ASHRM 2025
At the ASHRM Annual Conference, ECRI thought leaders urged healthcare organizations to strengthen risk strategies—addressing AI governance, embedding human factors into workflows, and improving maternal outcomes through PSO collaboration.
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ECRI Announces 2025 Healthcare Supply Chain Excellence Award Winners
Twelve US health systems receive ECRI’s top honor for excellence in supply chain practices.
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New Platform Offers Remote Monitoring for ST108 Water Quality Compliance
The cloud-based system is designed to track water purification performance and help facilities meet sterile processing standards.
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FDA Expands Early Alert Program for High-Risk Device Issues
The initiative provides faster notifications on potentially high-risk removals or corrections for all medical devices.
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Commerce Department Launches National Security Investigation into Medical Device Imports
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.
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US Indicts Suspect in Ransomware Campaigns That Disrupted Healthcare Systems
The US Department of State is offering up to $11 million for information leading to the arrest of Volodymyr Tymoshchuk, accused of deploying ransomware that targeted hospitals, companies, and major industrial firms
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3M Company Corrects Ranger Blood/Fluid Warming System
The action addresses a discrepancy between the device’s labeled and actual performance at high flow rates, which could pose a risk of patient hypothermia.
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Joint Commission Names Inaugural Recipient of the 2025 Healthcare Innovation Award
Tampa General Hospital is honored for integrating new strategies and technologies to improve patient safety and care quality.
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