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.
Tag: FDA clearance
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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.
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FDA Clears 3T Neonatal MRI System Designed for Use in the NICU
The system features a compact footprint and is designed for whole-body imaging in neonatal care settings.
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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 Siemens Healthineers’ 70cm Magnetom Flow 1.5T MRI system
The platform uses a closed helium circuit and AI-based workflows to reduce helium use, energy consumption, and exam time.
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FDA Clears for Augmented Reality Navigation Platform for Neurosurgery
The system is designed to give surgeons a clear, real-time view of critical anatomy and planned trajectories.
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FDA to Accept De-identified Data for Certain Medical Devices Submissions
New guidance permits the use of de-identified data without requiring individual patient information in marketing submissions.
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FDA Clears Robotic-assisted Surgery System for Urologic Procedures
The system is indicated for use in minimally invasive urologic surgical procedures including prostatectomy, nephrectomy, and cystectomy.
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FDA Clears Sirona Cloud-Native Imaging Suite for PET-CT Support
The platform’s 510(k) clearance adds PET-CT workflows—including SUV quantification, fusion, MIP, and MPR—to its browser-based diagnostic environment, advancing unified cloud imaging infrastructure.
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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 Clears YorLabs Intracardiac Imaging System
The no-capital-expenditure ultrasound platform is designed to simplify workflow, reduce cost, and enhance procedural efficiency inside the cath lab.
