AI-Enhanced Cardiovascular Ultrasound Launches With 4D Imaging Capabilities
The recently cleared system is designed with a new imaging architecture and AI-driven tools to enhance workflow efficiency and diagnostic speed.
Tag: FDA clearance
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FDA OKs Remote Scanning Platform Covering MR, CT, PET/CT, and Ultrasound
The vendor-agnostic system enables remote scanning in a command center configuration and real-time remote expertise.
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FDA Clears New Tool for Managing Respiratory Motion in Radiation Therapy
The newly cleared system uses a disposable sensor and software to track breathing motion in real-time during image-guided radiation therapy.
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AI-Enhanced Cardiovascular Ultrasound Launches With 4D Imaging Capabilities
The recently cleared system is designed with a new imaging architecture and AI-driven tools to enhance workflow efficiency and diagnostic speed.
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.
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FDA Clears Nanox.ARC X Imaging System
The system is cleared to produce tomographic images for general use, including musculoskeletal, pulmonary, intra-abdominal, and paranasal indications.
