FDA Clears Wireless Maternal-Fetal Monitoring Platform
The wearable sensor system provides continuous, simultaneous monitoring of maternal and fetal vital signs to improve clinical evaluation.
Category: Standards
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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.
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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FDA Clears Cardiovascular Monitoring Software for Surgical and ICU Settings
Argos Infinity analyzes existing physiologic data streams to provide early detection of hemodynamic instability without requiring new bedside hardware.
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FDA Clears Medtronic Robotic Spine Surgery System
The system brings surgical planning, real-time navigation, and robotic capabilities together in a single platform designed for spine procedures
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FDA Clears 3T Neonatal MRI System Designed for Use in the NICU
The system features a compact footprint and is designed for whole-body imaging in neonatal care settings.
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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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