FDA Clears New Device for Transseptal Heart Access
The system is designed to improve workflow efficiency and safety during minimally invasive left-heart procedures.
Tag: FDA clearance
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MARS Bioimaging Gains FDA Clearance for Portable Photon-Counting CT Scanner
The extremity-focused system is designed for point-of-care use, including clinics and ambulatory settings.
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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
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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.
FDA Clears Multi-Modality Breast Biopsy and Tissue Removal System
The newly cleared system is designed to support breast biopsy procedures across multiple imaging modalities using a single platform.
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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.
