FDA Clears Abbott Dual-Energy Cardiac Ablation Catheter
The TactiFlex Duo combines pulsed field ablation and radiofrequency energy in a single catheter for treating patients with atrial fibrillation.
Category: Clearances
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Clearances
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FDA Clears New Software for Draeger Evita V800 Ventilator
The update introduces features designed to assist clinicians in managing patients with pulmonary diseases like acute respiratory distress syndrome.
Clearances
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FDA OKs AI Early Warning System for Hospital Sepsis Detection
The technology, developed by Johns Hopkins University researchers, identifies sepsis cases up to 48 hours earlier than traditional methods and has reduced mortality rates by 18%.
Clearances
Latest
FDA Clears Abbott Dual-Energy Cardiac Ablation Catheter
The TactiFlex Duo combines pulsed field ablation and radiofrequency energy in a single catheter for treating patients with atrial fibrillation.
FDA Clears Hybrid Heart Imaging System
The platform combines ultrasound and optical imaging to provide detailed views of coronary anatomy in a single workflow.
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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.
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FDA Clears New Device for Transseptal Heart Access
The system is designed to improve workflow efficiency and safety during minimally invasive left-heart procedures.
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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 Deep Learning Technology for High-Resolution CT Imaging
The software is designed to enhance spatial resolution and suppress artifacts in pulmonary, musculoskeletal, and inner ear scans.
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Restore Robotics Receives FDA Clearance for Additional Remanufactured da Vinci Xi Instruments
Clearances expand options for hospitals seeking lower-cost alternatives to OEM robotic surgical instruments.
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Clearances
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FDA Clears Medtronic Surgical System for Cranial and ENT Procedures
The platform combines planning, navigation, and robotics, with AI-enabled features for imaging and workflow support.
