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.
Category: Clearances
Clearances
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Clearances
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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.
Clearances
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FDA Clears Medtronic Robotic Spine Surgery System
The system brings surgical planning, real-time navigation, and robotic capabilities together in a single platform designed for spine procedures
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.
FDA Clears AI Tool for Coronary Plaque Analysis
The clearance enables on-premise AI analysis of coronary CT angiography for quantifying calcified and non-calcified plaque.
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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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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.
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FDA Clears AI Tool to Help Detect Lung Nodules and Triage Chest X-Rays
New FDA clearances authorize the use of an AI tool to detect lung nodules and help triage pneumothorax and pleural effusion on chest X-rays.
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FDA OKs Inogen Simeox 200 Airway Clearance Device
The Inogen Simeox 200 Airway Clearance Device aids bronchial drainage in patients with chronic respiratory conditions using high-frequency oscillatory vibrations and intermittent negative pressure.
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Clearances
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Movano’s EvieMED Ring Cleared by FDA for Pulse Oximeter
Movano Health’s EvieMED Ring received FDA 510(k) clearance for its pulse oximeter, enabling expansion into clinical markets.
