MARS Bioimaging Gains FDA Clearance for Portable Photon-Counting CT Scanner
The extremity-focused system is designed for point-of-care use, including clinics and ambulatory settings.
Category: Standards
Standards
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Standards
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Vermont Bill Would Give Hospitals and Independent Servicers the Right to Repair Medical Devices
H.160 would require original equipment manufacturers to provide documentation, parts, and tools needed to diagnose, maintain, and repair medical equipment on fair and reasonable terms.
FDA Updates Medical Device Cybersecurity Guidance to Address New Federal Requirements
Revised guidance aligns with quality management system regulation changes and provides recommendations for cyber device submissions under section 524B of the FD&C Act.
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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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