FDA Clears GE HealthCare CT System for Cardiac Imaging
The system uses AI-powered tools to speed up workflows and is designed to handle complex cardiac cases.
Tag: FDA clearance
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FDA Clears AI-Guided Point of Care Ultrasound for Chronic Liver Diseases
The device combines ultrasound elastography with AI features to help clinicians assess liver fat and stiffness at the point of care for patients with chronic liver disease.
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FDA Clears Home Airway Clearance System That Syncs Breathing with Chest Compressions
The FDA has cleared a new home airway clearance system that synchronizes breathing with chest compressions to support patients with chronic lung diseases such as COPD, cystic fibrosis, and bronchiectasis.
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FDA Clears GE HealthCare CT System for Cardiac Imaging
The system uses AI-powered tools to speed up workflows and is designed to handle complex cardiac cases.
FDA Clears Olympus Endoscopes Designed for Improved Imaging Precision
The gastroscope and colonoscope use Extended Depth of Field technology to improve image clarity during GI procedures.
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FDA Clears Software to Assist Spine MRI Analysis
The decision-support tool assists in the evaluation of previously acquired lumbar spine MRIs.
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FDA Clears Basivertebral Nerve Ablation System for Low Back Pain
The system targets the basivertebral nerve to provide relief from chronic vertebrogenic low back pain.
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FDA Clears AI Tool to Assist with Fetal Heart Ultrasound Scans
The tool automatically detects the standard views required for second- and third-trimester fetal heart ultrasound evaluations.
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FDA Clears Voice-Assisted Interventional X-Ray System
The interventional X-ray system uses voice commands, advanced imaging, and flexible positioning to support clinical staff during procedures.
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FDA Clears Dual-head SPECT/CT System and Companion AI Image Reconstruction Tool
Newly cleared technologies aim to improve image quality, streamline workflows, and support a range of clinical applications across nuclear medicine.
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AI-Driven Coronary Physiology Software Gains FDA Clearance
The software, powered by artificial intelligence and deep learning, assesses angiography-derived coronary physiology in patients with ischemic coronary artery disease.
