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.
Category: 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.
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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.
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.
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.
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FDA Clears Clarius Mobile Health OB AI Fetal Biometric Tool
Clarius Mobile Health has received U.S. FDA clearance for its OB AI tool, which uses deep learning to provide accurate fetal measurements.
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AliveCor Unveils AI-Powered Portable ECG Systems
AliveCor has launched the FDA-cleared KAI 12L AI technology and the Kardia 12L ECG System portable ECG solutions.
