FDA Clears Philips AI-Powered Spectral CT Imaging System
The system uses artificial intelligence for image reconstruction to improve diagnostic precision and workflow efficiency in radiology, cardiology, and oncology.
Category: Standards
Standards
Latest
Standards
Latest
Texas Directs Healthcare Facilities to Align With FDA Medical Device Cybersecurity Guidance
State officials are urging hospitals to review device cybersecurity risks and align policies with FDA guidance.
Standards
Latest
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.
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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.
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FDA Recognizes AAMI CR515 for AI- and ML-enabled Device Cybersecurity
The consensus report is now on FDA’s recognized standards list, giving manufacturers a clearer reference point and hospitals another document to ask about during purchase and support discussions.
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Joint Commission Partners With STS and ACC on Outcomes-Based Cardiac Certification
The new certification will use existing clinical registry data from STS and ACC to measure patient outcomes while reducing reporting burden for hospitals.
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Joint Commission to Align Sentinel Events List With NQF Serious Reportable Events
The change, effective in 2027, is intended to simplify patient safety reporting and reduce administrative burden for healthcare organizations.
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FDA Clears GE HealthCare’s MIM LesionID Pro for Automated Tumor Burden Analysis
The AI-enabled software automates whole-body tumor burden analysis for PSMA PET/CT and SPECT/CT studies to help clinicians assess treatment eligibility and monitor response.
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FDA Clears Platform for Noninvasive Cardiac Conduction System Visualization
The CTA-based system creates a patient-specific 3D map of the cardiac conduction system to support planning and guidance during procedures such as TAVR and conduction system pacing.
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FDA Clears Single-Use Articulating Laparoscope for Minimally Invasive Surgery
The 5mm Saberscope features a 90-degree articulating tip and integrated camera designed to reduce fogging and eliminate reprocessing needs.
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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.
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Why the Service Manual is the Master Key to the HTM Device Lifecycle
Service manuals aren’t optional or proprietary “extras” in a hospital. They’re required for safe maintenance and compliance, and they should be non-negotiable at purchase.
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New FDA-Approved Therapy Brings At-Home Electrical Field Treatment to Pancreatic Cancer Care
The wearable system uses alternating electrical fields to disrupt cancer cell division and can be used continuously during daily activities.
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GE HealthCare Receives FDA Clearance for Three New MRI Systems
The SIGNA portfolio includes a helium-free 1.5T system, advanced 3T scanner, and AI-driven workflow platform designed to improve imaging efficiency.
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