Could Vermont Crack the Code on Right to Repair? (Editor’s Message)
A recent hearing in Vermont shows lawmakers are asking more pointed questions about medical device repair. What happens next may depend on whether HTM professionals speak up.
Category: Standards
Standards
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Standards
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GE HealthCare Receives FDA Clearance for Diagnostic Imaging Viewer
The zero-footprint diagnostic viewer is designed to give radiologists browser-based access to imaging studies and visualization tools within the Genesis Radiology Workspace.
What 2025’s Healthcare Breaches Taught Us and Why 2026 Raises the Stakes
Lessons from 2025’s breaches point to a tougher reality in 2026, as AI adoption accelerates and cybersecurity becomes inseparable from patient care.
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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.
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AI Chatbots Top Annual List of Health Technology Hazards
ECRI’s report also sounds the alarm on insufficient planning for systems outages, substandard medical products, missed recalls of home diabetes management devices, and more.Â
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GAO Report Finds FDA Struggles to Meet Medical Device Recall Termination Goals
The agency exceeded its three-month termination timeline for 74% of recalls during fiscal years 2020-2024, due to staff constraints that limited oversight activities, the report finds.
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FDA Clears Elekta’s AI-Powered CT-Linear Accelerator
Elekta’s Evo system combines CT-guided radiation therapy with AI-enhanced imaging designed to support visualization of tumors and nearby organs at risk during treatment.
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FDA Clears Silicon Photonics System for Lung Biopsy Procedures
The system integrates depth imaging technology directly into biopsy tools to improve tissue sampling accuracy during bronchoscopy.
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FDA Clears Multi-Modality Breast Biopsy and Tissue Removal System
The newly cleared system is designed to support breast biopsy procedures across multiple imaging modalities using a single platform.
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24×7 Appoints Medical Device Cybersecurity Expert to Advisory Board
The cybersecurity veteran joins 24×7’s advisory board as cyber resilience becomes a growing focus for the HTM field.
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Fresenius Kabi Removes Ivenix Large-Volume PumpsÂ
A misassembly defect in a specific lot of Ivenix primary administration sets could cause reverse flow, delayed infusion, or serious patient harm, prompting a Class I recall.
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Baxter Removes Sigma Spectrum Infusion System Platforms
The removal is tied to incorrect software installations that could result in inaccurate flow rates and user confusion during clinical use.
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Most Healthcare Organizations Report Operational or Clinical Impact From Cyber Threats
More than 70% of respondents reported financial, operational, or clinical impacts from cyber incidents, according to a recent survey.
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Draeger Pulls Certain ErgoStar Catheter Mounts After Reports of Hose Cracking
The company is asking facilities to stop using affected mounts and return unused stock; cracks can cause leakage that may restrict ventilation if uncompensated.
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