FDA Clears New Disinfectant for Endoscope Reprocessing
The disinfectant is designed for use in compatible automated systems to support the safe reuse of endoscopes.
Category: Clearances
Clearances
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Clearances
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Masimo Receives FDA Clearance for Opioid-Induced Respiratory Depression Detection Feature
The new capability for the Radius VSM wearable monitor uses pattern-recognition technology to analyze continuous patient data and help clinicians identify early signs of opioid-related respiratory risk.
Clearances
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FDA Clears Six Siemens Healthineers Interventional Imaging Systems with AI
The new Artis portfolio features an AI-powered imaging chain designed to improve image quality and noise reduction during interventional procedures.
Clearances
Latest
FDA Clears New Disinfectant for Endoscope Reprocessing
The disinfectant is designed for use in compatible automated systems to support the safe reuse of endoscopes.
Philips Receives FDA Clearance for Rembra CT Platform
Clearances for Rembra CT, Rembra RT, and Areta RT aim to enable high-throughput imaging at scale and elevate precision across the cancer care pathway.
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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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Clearances
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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.
