The partnership between the Food and Drug Administration and the Medicines and Healthcare products Regulatory Agency aims to streamline technology access and reduce regulatory duplication.
Clearances expand options for hospitals seeking lower-cost alternatives to OEM robotic surgical instruments.
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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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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The change, effective in 2027, is intended to simplify patient safety reporting and reduce administrative burden for healthcare organizations.
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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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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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The 5mm Saberscope features a 90-degree articulating tip and integrated camera designed to reduce fogging and eliminate reprocessing needs.
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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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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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The wearable system uses alternating electrical fields to disrupt cancer cell division and can be used continuously during daily activities.
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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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Argos Infinity analyzes existing physiologic data streams to provide early detection of hemodynamic instability without requiring new bedside hardware.
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The system brings surgical planning, real-time navigation, and robotic capabilities together in a single platform designed for spine procedures
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