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AIFRED HEALTH完成北美临床试验&启动美国和加拿大监管机构对其AI驱动临床决策支持设备的审批程序,以优化重度抑郁症的治疗选择

AIFRED HEALTH CONCLUDES NORTH AMERICAN CLINICAL TRIAL & INITIATES U.S AND CANADIAN REGULATORY APPROVAL PROCESS FOR ITS AI-DRIVEN CLINICAL DECISION SUPPORT DEVICE TO OPTIMIZE TREATMENT CHOICE IN MAJOR DEPRESSION

CISION 等信源发布 2024-01-25 21:00

可切换为仅中文


MONTREAL, Jan. 25, 2024 /PRNewswire/ - Aifred Health, an award-winning digital healthcare company, today announced the conclusion of its North American Clinical Trial and initiation of the preparation of regulatory filings to seek US and Canadian approval for its novel AI-driven clinical decision support platform.

蒙特利尔,2024年1月25日/PRNewswire/-Aifred Health,一家屡获殊荣的数字医疗保健公司,今天宣布其北美临床试验结束,并开始准备监管文件,以寻求美国和加拿大对其新型人工智能驱动的临床决策支持平台的批准。

Aifred's proprietary technology was developed to personalize treatment choice for patients suffering from moderate to severe depression where treatment guidelines call for the use of medication and where clinicians lack adequate tools to personalize and optimize the choice and management of treatment..

艾弗雷德的专有技术是为患有中度至重度抑郁症的患者开发的,这些患者的治疗指南要求使用药物,而临床医生缺乏足够的工具来个性化和优化治疗的选择和管理。。

Aifred's technology was developed using high quality clinical data from clinical trials evaluating therapeutic treatments of depression. Using patient and clinician-completed questionnaires that integrate into the clinical workflow, Aifred's software device was developed with and for treating clinicians (family doctors, nurse practitioners and psychiatrists) who today have limited tools to personalize and facilitate the management of the therapeutic choice for patients, leading to what is for many patients a lengthy and painful trial-and-error process.

艾弗雷德的技术是利用评估抑郁症治疗方法的临床试验中的高质量临床数据开发的。Aifred的软件设备是使用患者和临床医生完成的问卷整合到临床工作流程中,与临床医生(家庭医生、护士从业者和精神科医生)一起开发的,用于治疗临床医生(家庭医生、护士从业者和精神科医生),这些临床医生如今只有有限的工具来个性化和促进患者治疗选择的管理,导致对许多患者来说是一个漫长而痛苦的试错过程。

Aifred's software is intended to support clinical decision making and improve this experience for patients and clinicians alike..

Aifred的软件旨在支持临床决策,并改善患者和临床医生的这种体验。。

Commenting on the trial and next steps, Marina Massingham, Aifred President & CEO, noted: 'We are incredibly proud to have concluded the trial, the first of its kind in the world for an AI-based clinical decision support tool in mental health, and excited to begin the preparation of our regulatory filings for the US FDA and Health Canada.

Aifred总裁兼首席执行官玛丽娜·马辛厄姆(MarinaMassingham)在评论这项试验和下一步行动时指出:“我们非常骄傲地完成了这项试验,这是世界上第一个基于人工智能的心理健康临床决策支持工具的试验,并且很高兴开始为美国FDA和加拿大卫生部准备监管文件。

Since our technology placed #1 in North America and #2 in the world in the IBM Watson AI XPRIZE, our team has been working tirelessly to prove the efficacy of our AI-driven device to meet the challenge of personalizing treatment choice that exists in many disease indications, but which is of such consequence in the treatment of moderate to severe depression and other related mental health conditions.'.

自从我们的技术在IBM Watson AI XPRIZE中排名北美第一、世界第二以来,我们的团队一直在不懈地努力证明我们的AI驱动设备的功效,以应对许多疾病适应症中存在的个性化治疗选择的挑战,但这在治疗中度至重度抑郁症和其他相关心理健康状况方面具有重要意义。”。

We have worked with some of the leading experts and centers of excellence for the treatment of depression in North America and are gratified by their support and enthusiasm as we tackle the key problem of improving personalized depression treatment, for the benefit of patients, families, employers, and healthcare systems.

我们与北美抑郁症治疗领域的一些领先专家和卓越中心合作,并对他们的支持和热情感到满意,因为我们解决了改善个性化抑郁症治疗的关键问题,为患者、家庭、雇主和医疗保健系统造福。

We are particularly grateful to have officially partnered with the US Dept. of Veterans Affairs (VA) and US Government for this trial and for the strong participation of the VA hospitals that have been an integral part of the trial. Finally, I would like to highlight the support of our key investors who have ensured that Aifred Health is fully funded through the projected approval of our technology in Canada and the US.'.

我们特别感谢与美国退伍军人事务部(VA)和美国政府正式合作进行这项试验,并感谢VA医院的大力参与,这些医院是试验的组成部分。最后,我想强调我们的关键投资者的支持,他们通过加拿大和美国对我们的技术的预期批准,确保了艾弗雷德健康公司得到了充分的资金。”。

Dr. David Benrimoh, Chief Scientific Officer, Aifred Health, added: 'We have been collaborating with clinicians and key clinical centres for more than 4 years to inform and guide our development of a decision support tool that will integrate into clinical workflow and be used by treating physicians to transform care and address the critical challenge of treatment choice in the area of moderate to severe depression.

David Benrimoh博士,Aifred Health首席科学官,补充道:“我们与临床医生和关键临床中心合作了4年多,为我们开发一种决策支持工具提供信息和指导,该工具将整合到临床工作流程中,并被治疗医生用于改变护理,并解决中度至重度抑郁症领域治疗选择的关键挑战。

We are working to complete the analysis of the data collected during the trial and to prepare it for peer-reviewed publication and submission to regulatory authorities in order to pave the way for widespread adoption of our tool.'.

我们正在努力完成对试验期间收集的数据的分析,并为同行评审的出版物和提交给监管机构做好准备,以便为广泛采用我们的工具铺平道路。”。

About Aifred Health's Technology

关于Aifred Health的技术

Aifred Health uses deep learning models and data pre-processing techniques developed in-house to generate models of differential treatment response. These models can be used in any situation where multiple treatments for a condition are available and are trained to predict treatment outcomes for individual treatment options..

Aifred Health使用内部开发的深度学习模型和数据预处理技术来生成差异治疗反应模型。这些模型可以在任何情况下使用,在这种情况下,可以对一种疾病进行多种治疗,并经过训练来预测个体治疗方案的治疗结果。。

About Aifred Health

关于Aifred Health

Aifred Health, a Montreal-based digital healthcare company, is delivering clinician-focused solutions for the treatment of mental health including a world-class AI approach to providing clinical decision support in mental health. In June 2021, Aifred's AI technology placed # 1 in North America and #2 in the world in the Global IBM WATSON AI XPRIZE.

总部位于蒙特利尔的数字医疗保健公司Aifred Health正在提供以临床医生为中心的心理健康治疗解决方案,包括世界级的人工智能方法,以提供心理健康的临床决策支持。2021年6月,艾弗雷德(Aifred)的人工智能技术在全球IBM WATSON AI XPRIZE中排名北美第一,世界第二。

Aifred initiated its regulatory approval clinical trial for decision support in major depression in Q2 2022 and has promising work already underway to extend its technology to a second indication in mental health. For more information, please visit www.aifredhealth.com..

艾弗雷德(Aifred)于2022年第二季度启动了针对重性抑郁症决策支持的监管批准临床试验,并且已经在进行有希望的工作,以将其技术扩展到心理健康的第二个适应症。有关更多信息,请访问www.aifredhealth.com。。

SOURCE Aifred Health Inc.

来源Aifred Health Inc。