WASHINGTON, May 2, 2024 /PRNewswire/ -- MCRA, the leading privately held independent medical device, diagnostics, and biologics Clinical Research Organization (CRO) and advisory firm is pleased to announce its role in the successful granting of Darmiyan's De Novo request for BrainSee by the U.S. Food and Drug Administration (FDA)..

华盛顿，2024年5月2日/PRNewswire/--MCRA是领先的私营独立医疗器械、诊断和生物制品临床研究组织（CRO）和咨询公司，很高兴宣布其在美国食品和药物管理局（FDA）成功批准Darmiyan的BrainSee从头申请中的作用。。

MCRA announces its role in the successful granting of Darmiyan's De Novo request for BrainSee by the FDA.

MCRA宣布其在FDA成功批准Darmiyan重新申请BrainSee方面的作用。

Darmiyan retained MCRA in 2021 for its broad and deep experience in Neurology, Digital Health, and Artificial Intelligence (AI). MCRA's team of regulatory experts collaborated closely with Darmiyan to achieve a Breakthrough Device Designation for BrainSee in 2021, develop the evidence and strategy for submission of a De Novo request in 2022, and navigate the rigorous FDA review process to secure granting of the De Novo request from FDA in January 2024..

Darmiyan于2021年保留了MCRA，因为它在神经病学，数字健康和人工智能（AI）方面拥有广泛而深刻的经验。MCRA的监管专家团队与Darmiyan密切合作，在2021年为BrainSee实现了突破性的设备指定，制定了2022年提交从头请求的证据和策略，并通过严格的FDA审查程序，确保FDA在2024年1月批准从头请求。。

BrainSee's AI algorithm combines analysis of an indicated patient's brain MRI with their results on cognitive tests to provide a BrainSee score. The score helps doctors determine the patient's likelihood of progression from amnestic mild cognitive impairment (MCI) to Alzheimer's dementia in the next 5 years.

BrainSee的AI算法将对指定患者大脑MRI的分析与认知测试结果相结合，以提供BrainSee评分。该评分有助于医生确定患者在未来5年内从遗忘性轻度认知障碍（MCI）发展为阿尔茨海默氏痴呆的可能性。

BrainSee is a first-of-a-kind medical device and represents a major advancement in Alzheimer's diagnostics..

BrainSee是一种一流的医疗设备，代表着阿尔茨海默氏病诊断的重大进步。。

John Doucet, Vice President, Neurology Regulatory Affairs – Neuromodulation and Evolving Technologies at MCRA states, 'We are proud to have worked closely with Darmiyan to achieve both Breakthrough Device Designation and marketing authorization from the FDA for BrainSee. Working with Darmiyan was a great example of expert collaboration between MCRA's Neurology and Digital Health regulatory teams.

MCRA负责神经调节和进化技术的神经病学监管事务副总裁约翰·杜塞特（JohnDoucet）表示，“我们很荣幸与达米扬（Darmiyan）密切合作，实现了BrainSee的突破性设备设计和FDA的上市授权。与Darmiyan合作是MCRA神经病学和数字健康监管团队之间专家合作的一个很好的例子。

Both groups contributed significantly from the very beginning of our collaboration with Darmiyan. Together we developed an integrated strategy that merged our understanding of the science, regulations, and policy needed to obtain FDA marketing authorization for such a novel and important product. We are proud to offer this unique combination of talent to help companies like Darmiyan bring innovative devices to market.'.

从我们与Darmiyan合作的一开始，这两个小组就做出了重大贡献。我们共同制定了一项综合战略，融合了我们对科学，法规和政策的理解，以获得FDA对这种新颖而重要的产品的营销授权。我们很自豪能够提供这种独特的人才组合，帮助Darmiyan等公司将创新设备推向市场。”。

Alex Cadotte, Vice President, Digital Health, Artificial Intelligence, and Radiology at MCRA said, 'As the use of AI in medical technology increases and spreads from Radiology to Neurology and other clinical specialties, it is vital to have a diverse and collaborative team of subject matter experts as you navigate through the FDA.

MCRA负责数字健康、人工智能和放射学的副总裁亚历克斯·卡多特（AlexCadotte）说，“随着人工智能在医疗技术中的使用增加，并从放射学扩散到神经病学和其他临床专业，在FDA中导航时，拥有一支多元化和协作的主题专家团队至关重要。

Darmiyan's BrainSee software platform required a regulatory strategy that merged MCRA's scientific and regulatory expertise in AI, Digital Health, and Neurology. We thank Darmiyan for trusting us to help secure the approval for this important new product.'.

Darmiyan的BrainSee软件平台需要一种监管策略，该策略融合了MCRA在人工智能、数字健康和神经病学方面的科学和监管专业知识。我们感谢Darmiyan信任我们，帮助我们获得这一重要新产品的批准。”。

Kaveh Vejdani, Co-founder, Chief Medical & Technology Officer at Darmiyan said, 'Darmiyan feels extremely fortunate to have partnered with MCRA to support our successful FDA submissions. The FDA Breakthrough Device Designation for BrainSee was a critical foundation for FDA collaborations during development, review, and granting of the De Novo request.

Darmiyan的联合创始人、首席医疗技术官KavehVejdani说，“Darmiyan感到非常幸运，能够与MCRA合作，支持我们成功提交FDA。BrainSee的FDA突破性设备指定是FDA在开发，审查和批准从头请求期间合作的关键基础。

MCRA is truly unique to have world-class scientific and regulatory expertise in Neurology, Digital Health, and AI that are needed to guide novel and ground-breaking devices like BrainSee through the FDA review process. MCRA's level of support spanned the entire spectrum and included leading our interactions with FDA, collaborating on development of test protocols, and assistance with writing the submissions.'.

MCRA在神经病学、数字健康和人工智能方面拥有世界一流的科学和监管专业知识，这是指导BrainSee等新型突破性设备通过FDA审查过程所必需的。MCRA的支持水平跨越了整个范围，包括领导我们与FDA的互动，合作开发测试协议，以及协助撰写提交文件。”。

About MCRA, LLC: MCRA is the leading privately held independent medical device, diagnostics, and biologics Clinical Research Organization (CRO) and advisory firm. MCRA delivers to its client's industry experience, integrating its seven business value creators: regulatory, clinical research, reimbursement, healthcare compliance, quality assurance, cybersecurity and distribution logistics to provide a dynamic, market-leading effort from innovation conception to commercialization.

关于MCRA，LLC：MCRA是领先的私营独立医疗器械，诊断和生物制品临床研究组织（CRO）和咨询公司。MCRA为客户的行业经验提供服务，整合了七大商业价值创造者：监管、临床研究、报销、医疗保健合规、质量保证、网络安全和分销物流，以提供从创新概念到商业化的动态、市场领先的努力。

MCRA's integrated application of these key value-creating initiatives provides unparalleled value for its clients. MCRA has offices in Washington, DC, Hartford, CT, New York, NY, London, England, Winterthur, Switzerland, Eschborn, Germany and Tokyo, Japan and serves nearly 1,000 clients globally. Its core focus areas of therapeutic experience include orthopedics, spine, biologics, cardiovascular, diagnostic imaging, wound care, artificial intelligence, dental, anesthesia, respiratory, ENT, general surgery, digital health, neurology, robotics, oncology, general and plastic surgery, urology, and in vitro diagnostic (IVD) devices. www.mcra.com .

MCRA对这些关键价值创造计划的综合应用为其客户提供了无与伦比的价值。MCRA在华盛顿特区、康涅狄格州哈特福德、纽约、纽约、伦敦、英国、瑞士温特图尔、德国埃斯伯恩和日本东京设有办事处，为全球近1000家客户提供服务。其治疗经验的核心重点领域包括骨科、脊柱、生物制剂、心血管、诊断成像、伤口护理、人工智能、牙科、麻醉、呼吸、耳鼻喉科、普外科、数字健康、神经病学、机器人学、肿瘤学、普通和整形外科、泌尿外科和体外诊断（IVD）设备。www.mcra.com。

About Viscogliosi Brothers, LLC: Viscogliosi Brothers, LLC (VB), founded MCRA in 2004. VB is headquartered in New York City and specialized in funding venture capital, private equity, and merchant banking activities for the neuromusculoskeletal industry. VB is dedicated to financing healthcare innovation. www.vbllc.com.

关于Viscogliosi Brothers，LLC：Viscogliosi Brothers，LLC（VB）于2004年成立了MCRA。VB总部位于纽约市，专门为神经肌肉骨骼行业的风险投资、私人股本和商业银行活动提供资金。VB致力于为医疗创新融资。www.vbllc.com。

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 monitoring. The company's mission is to enhance brain health, equipping physicians with tools for precise and personalized patient care, thereby optimizing health outcomes.

关于Darmiyan：Darmiyan是加利福尼亚州旧金山的一家领先的大脑技术（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。该公司的使命是增强大脑健康，为医生提供精确且个性化的患者护理工具，从而优化健康结果。

www.darmiyan.com.

www.darmiyan.com。

For more information, please contact:

有关更多信息，请联系：

Alyssa Howard, Vice President, Business Development

Alyssa Howard，业务发展副总裁

Phone: 215.870.3952 | Email: ahoward@mcra.com

电话：215.870.3952|电子邮件：ahoward@mcra.com

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SOURCE MCRA, LLC

SOURCE MCRA有限责任公司