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.
Category: Clearances
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HeartBeam Arrhythmia Assessment System Earns FDA Clearance
HeartBeam announced that the FDA has granted 510(k) clearance of the HeartBeam system for comprehensive arrhythmia assessment.
Clearances
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REMI Vigilenz AI EEG Notifications Earn FDA Clearance
Epitel's REMI Vigilenz AI For Bedside Notifications has received FDA 510(k) clearance, notifying clinicians of potential seizures.
Clearances
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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.
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.
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Postrigo NeuroLF PET System Nabs FDA Clearance
Positrigo, a Swiss company, received FDA clearance for its NeuroLF brain PET system, designed to diagnose and monitor brain disorders.
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FDA Clears ImmersiveTouch ImmersiveAR Platform
ImmersiveTouch has received FDA clearance for its ImmersiveAR platform, an augmented reality technology to enhance surgical planning.
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FDA OKs AgileMD eCART Clinical Deterioration Suite
The FDA has granted 510(k) marketing clearance for AgileMD's eCART Clinical Deterioration Suite for assessing patient condition.
