林业发展局授予Ceribell的AI EEG工具以突破性地位,以便更快地在医院内检测中风。
FDA grants breakthrough status to Ceribell’s AI EEG tool for faster in-hospital stroke detection.
Ceribell接受了FDA为AI驱动的EEG系统提供的 " 突破装置标识 " ,该系统可检测住院病人的大型船舶隔离中风,旨在减少诊断和治疗的延误。
Ceribell has received FDA Breakthrough Device Designation for an AI-powered EEG system that detects large vessel occlusion strokes in hospitalized patients, aiming to reduce delays in diagnosis and treatment.
该技术利用现有硬件和先进的算法分析脑波信号,弥补医院内中风护理中的重大差距,早期发现往往有限。
The technology uses existing hardware and an advanced algorithm to analyze brainwave signals, addressing a critical gap in in-hospital stroke care where early detection is often limited.
FDA的指定加快了开发和审查,建立在此前新生儿癫痫和谵妄监测的批准基础上。
The FDA’s designation accelerates development and review, building on prior clearances for neonatal seizure and delirium monitoring.
医院内中风占美国每年病例的17%,由于干预延迟,其死亡率更高,结果更糟糕。
In-hospital strokes, which account for up to 17% of annual U.S. cases, face higher mortality and worse outcomes due to delayed intervention.
该系统支持持续的床边监测,并可提高回收率。
The system supports continuous bedside monitoring and could improve recovery rates.