FDA Clears Mobile C-Arm System With AI-Enhanced Imaging
The mobile C-arm system features AI-powered imaging tools and cable-free design for interventional procedures.
Category: Clearances
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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.
Clearances
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LifeSignals UbiqVue 2A Monitoring System Earns FDA Clearance
LifeSignals’ UbiqVue 2A Multiparameter System wireless patient monitoring wearable has received FDA Class II 510(k) clearance.
Clearances
Latest
FDA Clears Mobile C-Arm System With AI-Enhanced Imaging
The mobile C-arm system features AI-powered imaging tools and cable-free design for interventional procedures.
Natus Medical Submits FDA 510(k) for Point-of-Care EEG Device
Natus Medical submitted an FDA 510(k) notification for its point-of-care EEG device, designed to identify seizures in acute care settings.
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FDA OKs SamanTree Medical Histolog Scanner
SamanTree Medical’s Histolog Scanner has received FDA 510(k) clearance for imaging the internal microstructure of tissues, such as cells and vessels.
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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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Clearances
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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.
