FDA Clears New AI Tool for Cardiac Ultrasound Assessments
The tool from Clarius Mobile Health automates heart function measurements to assist clinicians in primary care and emergency settings.
Category: Clearances
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Clearances
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Olympus Receives FDA Clearance for Open Surgery Sealing Device
The new Powerseal Open Extended Jaw device is the fourth addition to the company's advanced bipolar surgical energy portfolio.
Clearances
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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.
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FDA Clears New AI Tool for Cardiac Ultrasound Assessments
The tool from Clarius Mobile Health automates heart function measurements to assist clinicians in primary care and emergency settings.
GE HealthCare’s Photonova Spectra Photon-counting CT Receives FDA Clearance
The cleared system introduces photon-counting CT designed to capture spectral data in a single scan and reduce protocol complexity.
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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 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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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.
