FDA Clears Silicon Photonics System for Lung Biopsy Procedures
The system integrates depth imaging technology directly into biopsy tools to improve tissue sampling accuracy during bronchoscopy.
Category: Clearances
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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 Philips’ Spectral CT 7500 RT for Radiation Oncology
Philips' Spectral CT 7500 RT, now FDA-cleared, integrates spectral CT into radiotherapy, enhancing tumor visualization and targeting.
Clearances
Latest
FDA Clears Silicon Photonics System for Lung Biopsy Procedures
The system integrates depth imaging technology directly into biopsy tools to improve tissue sampling accuracy during bronchoscopy.
FDA OKs AISAP Cardio Ultrasound Platform
AISAP has received U.S. FDA 510(k) clearance for its AI-powered AISAP Cardio platform, which provides comprehensive point-of-care cardiac ultrasound diagnostics and integrates into clinical workflows.
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FDA Clears Procept BioRobotics Hydros Robotic System
Procept BioRobotics has received FDA clearance for its AI-powered Hydros Robotic System, which integrates advanced imaging to improve urology procedures and will be available in U.S. hospitals soon.
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FDA OKs Siemens Healthineers Acuson Origin
Siemens Healthineers has received U.S. FDA clearance for the AI-powered Acuson Origin cardiovascular ultrasound system and the AcuNav Lumos 4D ICE catheter, both designed to improve cardiac diagnostics and patient care.
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Masimo W1 Watch Receives FDA Clearance for Connectivity
The Masimo W1 medical watch received FDA clearance for connectivity, enabling integration with the Masimo SafetyNet telemonitoring solution.
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Diality Receives FDA Clearance for Moda-flx Hemodialysis System
Diality has received U.S. FDA 510(k) clearance for its Moda-flx Hemodialysis System, designed to support various dialysis treatments and improve usability across multiple care settings.
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Varian Receives FDA Clearance for IntelliBlate Ablation System
Varian received FDA 510(k) clearance for its IntelliBlate microwave ablation system, designed for soft tissue ablation.
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FDA Grants Restore Medical ContraBand Breakthrough Designation
Restore Medical's ContraBand device received FDA Breakthrough Device Designation for treating heart failure with reduced ejection fraction.
