CeriBell, Inc. a medical technology company focused on transforming the diagnosis and management of patients with serious neurological conditions, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its proprietary delirium monitoring solution,1 the first and only FDA cleared delirium screening and monitoring device.

CeriBell公司是一家专注于改变严重神经疾病患者诊断和管理的医疗技术公司，今天宣布美国食品药品监督管理局（FDA）已授予其专有的谵妄监测解决方案510(k)许可，1 这是首个也是唯一获得FDA许可的谵妄筛查和监测设备。

This clearance further establishes the Ceribell System as an AI-powered brain monitoring platform technology, extending the benefits to a larger population of critically ill patients and providing additional information to assist in diagnosing patients at risk for both seizures and delirium..

这一批准进一步确立了 Ceribell 系统作为人工智能驱动的脑监测平台技术的地位，将益处扩展到更多重症患者，并提供更多信息以协助诊断有癫痫和谵妄风险的患者。

“Delirium has severe consequences for critically ill patients, including increased mortality, prolonged hospital stays, and long-term cognitive impairment, resulting in substantial burdens for families and healthcare systems,” said Juliana Barr, MD, professor emerita of anesthesiology, perioperative and pain medicine at Stanford University School of Medicine.

“谵妄对重症患者有严重后果，包括增加死亡率、延长住院时间以及造成长期认知障碍，给家庭和医疗系统带来沉重负担，”斯坦福大学医学院麻醉学、围手术期和疼痛医学荣休教授朱莉安娜·巴尔博士说道。

“Current detection methods rely on intermittent, labor-intensive bedside assessments that are subject to human variability. Ceribell offers a reliable continuous monitoring solution that has the potential to improve delirium detection rates and management, and reduce the high costs associated with missed or delayed diagnoses.”.

“当前的检测方法依赖于间歇性的、劳动密集型的床边评估，这些评估容易受到人为差异的影响。Ceribell 提供了一种可靠的持续监测解决方案，有望提高谵妄的检测率和管理水平，并降低因漏诊或诊断延误带来的高昂成本。”

Ceribell’s delirium monitoring solution continuously analyzes EEG segments and notifies clinicians when patterns associated with delirium are detected, supporting more timely, reliable evaluation, and continuous monitoring of delirium. This will allow the Ceribell System to simultaneously support continuous seizure, electrographic status epilepticus (ESE), and delirium monitoring at the bedside..

Ceribell的谵妄监测解决方案持续分析脑电图片段，并在检测到与谵妄相关的模式时通知临床医生，从而支持更及时、可靠的评估以及对谵妄的持续监测。这将使Ceribell系统能够在床旁同时支持持续的癫痫发作、脑电图癫痫持续状态（ESE）和谵妄监测。

Ceribell’s delirium algorithm was validated using EEG data and clinical assessments collected through rigorous prospective studies involving 225 adults aged 22 years or older in critical care environments. This validation underscores the algorithm’s reliability and real-world utility for continuous delirium monitoring in the critical care setting.

Ceribell的谵妄算法通过严格前瞻性研究收集的脑电图数据和临床评估进行了验证，这些研究涉及225名年龄在22岁或以上的重症监护环境中的成年人。这一验证强调了该算法在重症监护环境中进行持续谵妄监测的可靠性和现实应用价值。

FDA clearance follows Ceribell’s initial receipt of a Breakthrough Device Designation for delirium monitoring in 2022. Ceribell has submitted a New Technology Add-on Payment (NTAP) application to the Centers for Medicare and Medicaid Services (CMS) for this new indication..

FDA 的批准是在 Ceribell 于 2022 年首次获得用于谵妄监测的突破性设备认定之后进行的。Ceribell 已向美国医疗保险和医疗补助服务中心 (CMS) 提交了针对这一新适应症的新技术附加支付 (NTAP) 申请。

Delirium is a common and serious neurological condition affecting ~31% of ICU patients, and up to 80% of those who are mechanically ventilated.2,3 It is associated with poor clinical outcomes, including a 10% higher 6-month mortality risk for every day delirium is experienced,4 as well as longer hospital stays and increased hospitalization costs.5 The risk of post-ICU dementia is 60% higher in discharged ICU patients who have had delirium, compared to those who have not had delirium in the ICU.6 Current Society of Critical Care Medicine guidelines recommend regular delirium assessment using validated tools,7 underscoring the need for early and accurate detection.

谵妄是一种常见且严重的神经疾病，影响约31%的ICU患者，其中高达80%为机械通气患者。2,3 谵妄与不良临床结局相关，包括每经历一天谵妄，6个月内的死亡风险增加10%，4 同时还会导致住院时间延长和住院费用增加。5 与未在ICU中经历谵妄的出院患者相比，曾在ICU中出现谵妄的患者发生ICU后痴呆的风险高出60%。6 当前重症医学会指南建议使用经过验证的工具定期评估谵妄，7 强调了早期准确检测的重要性。

Nonetheless, delirium - particularly hypoactive delirium8 - often goes unrecognized due to challenges in clinical assessment and the lack of objective, continuous monitoring tools. Ceribell’s delirium monitoring solution addresses this gap by providing real-time, objective neurological insights at the bedside..

然而，由于临床评估的挑战和缺乏客观、持续的监测工具，谵妄——尤其是低活动型谵妄——常常未被识别。Ceribell的谵妄监测解决方案通过在床边提供实时、客观的神经学洞察来填补这一空白。

Moreover, studies have demonstrated a relationship between seizure and delirium, with one study showing that ~48% of patients experiencing seizures in the ICU had peri-ictal delirium,9 and another study finding epileptiform discharges in 42% of older ICU patients with delirium.10 By combining advanced seizure and delirium monitoring capabilities, the Ceribell System will help clinicians better understand patient presentation and support more timely clinical decision making..

此外，研究已经证明了癫痫发作与谵妄之间的关系，一项研究表明，约48%的在ICU中经历癫痫发作的患者出现了围发作期谵妄，另一项研究发现在患有谵妄的老年ICU患者中有42%存在癫痫样放电。通过结合先进的癫痫发作和谵妄监测功能，Ceribell系统将帮助临床医生更好地了解患者的病情表现，并支持更及时的临床决策。

“Delirium has been under recognized and under treated in critically ill patients for far too long, despite its strong association with poor outcomes,” said Jane Chao, Ph.D., co-founder and CEO of Ceribell. “With this FDA clearance, Ceribell is proud to expand EEG technology into delirium care, bringing the first objective, continuous monitoring solution to clinicians who urgently need better tools to support these vulnerable patients.

“长期以来，谵妄在重症患者中一直未被充分认识和治疗，尽管它与不良预后有很强的关联，”Ceribell联合创始人兼首席执行官Jane Chao博士表示。“通过此次FDA核准，Ceribell很自豪能够将脑电图技术扩展到谵妄护理领域，为迫切需要更好工具支持这些脆弱患者的临床医生提供首个客观、连续的监测解决方案。”

We expect to finalize our go-to-market strategy in the near future, and look forward to leveraging our existing commercial footprint and reputation as the category leader in AI-based neuro monitoring to bring this transformational technology to patients in need. This is another big step towards our mission of making EEG a new vital sign for better brain care.”.

我们预计将在不久的将来最终确定我们的上市战略，并期待利用我们现有的商业影响力和作为基于人工智能的神经监测领域的领导者声誉，将这项变革性技术带给有需要的患者。这是我们实现将脑电图作为新的重要指标以改善大脑护理使命的又一大步。"

References

参考文献

FDA 510k Clearance Letter K251936

FDA 510k 清关信 K251936

Krewulak, K.D., et al. (2018) Crit Care Med 46(12):p 2029-2035

克鲁瓦拉克，K.D. 等（2018）《重症监护医学》46(12): 第2029-2035页

Girard, T.D., et al. (2008). Crit Care 12 Suppl 3(Suppl 3):S3

吉拉德，T.D.，等（2008）。《重症监护》12卷增刊3（增刊3）：S3

Ely, E.W., et al. (2004) JAMA 291(14):1753-62

Ely, E.W. 等（2004）《美国医学会杂志》291(14):1753-62

Taha, A., et al. (2023) Medicine 102(2):e32652

塔哈，A.，等（2023）医学 102(2):e32652

Wang, S. et al. (2024) Alzheimer's & Dementia, 20(1), 278-287.

王，S. 等（2024）《阿尔茨海默病与痴呆》，20(1)，278-287。

Devlin, J.W., et al. (2018) Crit Care Med 46(9):e825-e873

德夫林，J.W. 等（2018）《重症医学》46(9):e825-e873

de Lourdes Ramírez Echeverría, M., et al. (2022) Delirium. In StatPearls [Internet]

M. de Lourdes Ramírez Echeverría 等（2022）谵妄。In StatPearls [Internet]

Frei, A.I., et al. (2024) Journal of Neurology, 271(1), pp.231-240

弗雷，A.I. 等（2024）《神经学杂志》，271卷第1期，第231-240页

Sambin, S., et al. (2019) Frontiers in neurology, 10, p.263.

萨宾，S. 等（2019）《神经病学前沿》，第10卷，第263页。

Forward-Looking Statements

前瞻性声明

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other statements that are not statements of historical fact. Forward-looking statements can be identified by the use of words such as “will,” “may,” “could,” “likely,” “ongoing,” “anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “believe,” “assume,” “target,” “forecast,” “guidance,” “goal,” “objective,” “aim,” “seek,” “potential,” “hope,” and other words of similar meaning.

本新闻稿包含1995年《私人证券诉讼改革法案》及其他非历史事实陈述的前瞻性声明。前瞻性声明可以通过使用诸如“将”、“可能”、“可能”、“很可能”、“正在进行”、“预期”、“估计”、“预计”、“预测”、“打算”、“计划”、“相信”、“假设”、“目标”、“展望”、“指导”、“目的”、“宗旨”、“旨在”、“寻求”、“潜在”、“希望”等类似含义的词语来识别。

These statements are based on management’s current expectations and assumptions and involve risks and uncertainties that could cause actual results to differ materially from those described. Such risks and uncertainties, including those related to regulatory approvals, clinical use and adoption, market acceptance, competition, and other factors, are described under the “Risk Factors” sections of our most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and other reports filed with the U.S.

这些声明基于管理层当前的预期和假设，并涉及可能导致实际结果与所述内容存在重大差异的风险和不确定性。这些风险和不确定性包括与监管审批、临床使用和采用、市场接受度、竞争及其他因素相关的内容，已在我们最近的年度报告 Form 10-K、季度报告 Form 10-Q 以及其他提交给美国证券交易委员会的文件中的“风险因素”部分进行了描述。

Securities and Exchange Commission (“SEC”). These filings are available on the SEC’s website at https://sec.gov/ and on Ceribell’s website at https://investors.ceribell.com/. Ceribell undertakes no obligation to update any forward-looking statements as a result of new information, future events, or otherwise, except as required by law..

证券交易委员会（“SEC”）。这些文件可在SEC的网站https://sec.gov/ 和Ceribell的网站https://investors.ceribell.com/ 上查阅。Ceribell没有义务因新信息、未来事件或其他原因更新任何前瞻性声明，除非法律要求。

About CeriBell, Inc.

关于CeriBell公司

Ceribell is a medical technology company focused on transforming the diagnosis and management of patients with serious neurological conditions. Ceribell has developed the Ceribell System, a novel, point-of-care electroencephalography (“EEG”) platform specifically designed to address the unmet needs of patients in the acute care setting.

Ceribell是一家医疗技术公司，专注于改变严重神经系统疾病患者的诊断和管理。Ceribell开发了Ceribell系统，这是一种新颖的即时护理脑电图（“EEG”）平台，专门设计用于满足急性护理环境中未被满足的患者需求。

By combining proprietary, highly portable, and rapidly deployable hardware with sophisticated artificial intelligence (“AI”)-powered algorithms, the Ceribell System enables rapid diagnosis and continuous monitoring of patients with neurological conditions. The Ceribell System is FDA-cleared for detecting seizure and delirium for use in intensive care units and emergency rooms across the U.S.

通过将专有的、高度便携且可快速部署的硬件与复杂的人工智能（“AI”）驱动算法相结合，Ceribell系统能够快速诊断和持续监测患有神经系统疾病的患者。Ceribell系统已获得FDA批准，可用于检测癫痫发作和谵妄，在美国各地的重症监护室和急诊室中使用。

Ceribell is headquartered in Sunnyvale, California. For more information, please visit www.ceribell.com or follow the company on LinkedIn..

Ceribell 总部位于加利福尼亚州桑尼维尔。欲了解更多信息，请访问 www.ceribell.com 或在 LinkedIn 上关注该公司。

Investor Contact

投资者联系

Brian Johnston or Laine Morgan

布赖恩·约翰斯顿或莱恩·摩根

Gilmartin Group

吉尔马丁集团

[email protected]

电子邮件地址

Media Contact

媒体联系人

Brian Price

布赖恩·普赖斯

[email protected]

电子邮件地址

Source: globenewswire.com

来源：globenewswire.com