FDA's De Novo approval of BrainSee represents a major advancement in Alzheimer's diagnostics. Utilizing cutting-edge image processing and medical AI, BrainSee establishes a new standard for predicting progression from amnestic mild cognitive impairment (aMCI) to Alzheimer's dementia. This breakthrough is a significant step in proactive brain health management, offering a fully non-invasive, convenient, and globally accessible screening solution, to be prioritized before other tests or treatments.SAN FRANCISCO, Jan.

FDA对BrainSee的从头批准代表了阿尔茨海默病诊断的重大进步。BrainSee利用尖端的图像处理和医学AI建立了一个新的标准，用于预测从遗忘性轻度认知障碍（aMCI）到阿尔茨海默氏痴呆的进展。这一突破是积极主动的大脑健康管理的重要一步，它提供了一种完全无创，方便且全球可访问的筛查解决方案，在其他测试或治疗之前优先考虑。旧金山，1月。

12, 2024 /PRNewswire/ -- Today marks a turning point in the battle against Alzheimer's disease as Darmiyan, Inc., a leading company in brain health innovation announces the FDA's approval of its first-in-class (De Novo) clinical test, BrainSee. This approval marks a pivotal advancement in brain health and opens the door to untapped market potential in brain disease diagnosis and management..

122024/PRNewswire/-今天标志着与阿尔茨海默氏病斗争的转折点，大脑健康创新的领先公司Darmiyan，Inc.宣布FDA批准其第一个一流（从头）临床试验BrainSee。这一批准标志着大脑健康取得了关键性进展，为大脑疾病诊断和管理领域尚未开发的市场潜力打开了大门。。

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(PRNewsfoto/Darmiyan)

（PRNewsfoto/Darmiyan）

BrainSee is the first clinical application of Darmiyan's patented core proprietary technology that is based on 40+ years of cutting-edge brain science, powered by advanced whole-brain image analysis and medical AI. It is a highly-scalable and fully-automated software platform that combines standard clinical brain MRI and cognitive assessments – part of the routine, non-invasive workup of patients concerned with memory loss – and generates an objective score that predicts the likelihood of progression from aMCI to Alzheimer's dementia within 5 years.

BrainSee是Darmiyan专利核心专有技术的首次临床应用，该技术基于40多年的尖端脑科学，由先进的全脑图像分析和医学AI提供支持。它是一个高度可扩展且全自动化的软件平台，结合了标准的临床脑MRI和认知评估-这是常规的一部分，对与记忆丧失有关的患者进行非侵入性检查，并产生一个客观评分，预测5年内从aMCI发展为阿尔茨海默病痴呆的可能性。

BrainSee addresses a critical unmet need for over 10 million Americans and over 100 million patients worldwide grappling with aMCI. With an aging global population, the socio-economic impact of BrainSee is expected to grow rapidly and exponentially..

BrainSee解决了全球1000多万美国人和一亿多患有aMCI的患者尚未满足的关键需求。随着全球人口老龄化，BrainSee的社会经济影响预计将迅速成倍增长。。

'Our vision is to redefine brain health screening and monitoring standards and impact the lives of patients and their family members in a meaningful way. BrainSee is the first product of this vision, backed by our solid technological infrastructure that is capable of driving further transformations and scalable innovations in the brain health landscape,' stated Dr. Padideh Kamali-Zare, Founder and CEO of Darmiyan..

“我们的愿景是重新定义大脑健康筛查和监测标准，并以有意义的方式影响患者及其家人的生活。Darmiyan创始人兼首席执行官帕迪德·卡马利·扎雷（PadidehKamaliZare）博士表示，BrainSee是这一愿景的第一个产品，有我们坚实的技术基础设施的支持，能够推动大脑健康领域的进一步变革和可扩展的创新。。

Early screening and risk stratification by BrainSee enables timely and personalized treatments for those aMCI patients at high risk of progression to Alzheimer's dementia, aiming to delay dementia onset, while reassuring those at lower risk of progression, hence reducing the need for costly and invasive tests and the heavy burdens of financial and emotional abuse.

BrainSee的早期筛查和风险分层能够为那些进展为阿尔茨海默氏痴呆症的高风险aMCI患者提供及时和个性化的治疗，旨在延缓痴呆症的发作，同时安抚那些进展风险较低的患者，从而减少对昂贵和侵入性测试的需求以及财务和情绪虐待的沉重负担。

This shifts the patient experience from prolonged anxiety to proactive management, which is crucial in an era of emerging Alzheimer's treatments where accurate prognosis can help determine suitable treatment candidates. The economic impact of BrainSee will be significant for all stakeholders in healthcare, promising to reduce the billions of dollars annually spent on Alzheimer's care, through more effective management and treatment.BrainSee was previously granted FDA breakthrough designation in 2021.

这将患者的经历从长期焦虑转变为主动管理，这在阿尔茨海默病治疗的新时代至关重要，准确的预后可以帮助确定合适的治疗候选人。BrainSee的经济影响将对医疗保健领域的所有利益相关者产生重大影响，有望通过更有效的管理和治疗，减少每年用于阿尔茨海默病护理的数十亿美元。BrainSee此前于2021年获得FDA突破性指定。

It stands out for its prognostic accuracy, patient convenience, same-day test results and seamless integration into the clinical workflow. Global availability of MRI significantly enhances BrainSee's clinical utility. Most notably, BrainSee shifts the paradigm in aMCI workup from biomarker-based methods that have limited real-world capabilities due to their invasiveness, non-specificity, cost, and inaccessibility, to non-invasive and actionable forecasts of future improvement or progression.BrainSee's FDA approval coincided with the JP Morgan HealthCare conference in San Francisco.

它以其预后准确性，患者便利性，当天测试结果以及与临床工作流程的无缝集成而脱颖而出。MRI的全球可用性显着增强了BrainSee的临床实用性。最值得注意的是，BrainSee将aMCI检查的范式从基于生物标志物的方法转变为对未来改进或进展的非侵入性和可操作的预测，这些方法由于其侵袭性，非特异性，成本和不可及性而限制了现实世界的能力。BrainSee获得FDA批准的时间恰逢在旧金山举行的摩根大通医疗保健会议。

The platform is now available to physicians via a secure and HIPAA-compliant web portal. For more information visit brainsee.ai.About Darmiyan:Darmiyan is a pioneering brain technology (deep-tech) company in San Francisco, California, focused on developing innovative and rapidly scalable products for brain health screening and monitorin.

该平台现在可通过安全且符合HIPAA的web门户提供给医生。有关更多信息，请访问brainsee.ai.关于Darmiyan：Darmiyan是加利福尼亚州旧金山的一家开创性大脑技术（deep tech）公司，专注于开发用于大脑健康筛查和监测的创新且快速扩展的产品。

SOURCE Darmiyan

来源Darmiyan