TUEBINGEN, Germany--(BUSINESS WIRE)--German medical technology company AIRAmed has announced U.S. Food and Drug Administration 510(k) clearance of AIRAscore, a medical image management and processing system providing relevant brain volumetry data to assist physicians in early detection of Alzheimer’s and other dementias.

德国图宾根-（商业线）-德国医疗技术公司AIRAmed宣布美国食品和药物管理局510（k）清除AIRAscore，这是一个医疗图像管理和处理系统，提供相关的脑容量数据，以帮助医生早期发现阿尔茨海默氏症和其他痴呆症。

AIRAscore uses deep learning and artificial intelligence (AI) technology to provide quantitative assessment of brain volume with objectively verifiable data using standard MRI brain scans in as little as five minutes..

AIRAscore使用深度学习和人工智能（AI）技术，在短短五分钟内使用标准MRI脑部扫描，通过客观可验证的数据提供脑容量的定量评估。。

According to the U.S. CDC, an estimated 5.8 million people in the United States have Alzheimer's disease and related dementias, including 5.6 million aged 65 and older and about 200,000 under age 65 with younger-onset Alzheimer's. Moreover, lifetime risk for Alzheimer’s at age 45 for women is one in five, and for men one in 10.1 Dementia has historically been diagnosed in more advanced stages, when potentially irreversible damage may have already occurred.

据美国疾病预防控制中心称，美国估计有580万人患有阿尔茨海默病和相关痴呆症，其中包括560万65岁及以上的老年人和约20万65岁以下的老年痴呆症患者。此外，女性45岁时阿尔茨海默氏症的终生风险为五分之一，男性10.1岁时痴呆症的终生风险历史上被诊断为更晚期，此时可能已经发生了不可逆转的损害。

Early and accurate detection is a key factor in positively influencing the course of the disease..

早期准确的检测是积极影响疾病进程的关键因素。。

“For so long, we’ve been limited to reading a patient’s MRI to detect Alzheimer’s and other dementias. However, we know from several studies that patients with these brain diseases suffer from subtle brain volume loss early in their disease course that cannot be observed with the human eye,” said Dr.

“长期以来，我们一直局限于阅读患者的MRI来检测阿尔茨海默氏症和其他痴呆症。然而，我们从几项研究中知道，患有这些脑部疾病的患者在疾病早期患有微妙的脑容量损失，这是无法观察到的用人眼，“博士说。

Tobias Lindig, founder and managing director, AIRAmed, and specialist in both radiology and neurology at University Hospital Tübingen. “With AIRAscore, we are now offering physicians a highly precise, quantitative tool for the rapid detection of areas with a brain volume below the normal range. We believe our technology has the potential to be a game changer in the patient care journey, as brain volumes are of interest to physicians in the early disease course and also during the course of a disease to monitor the brain volume over time during therapy.”.

蒂宾根大学医院放射学和神经病学的创始人兼总经理Tobias Lindig。“通过AIRAscore，我们现在为医生提供一种高度精确，定量的工具，用于快速检测脑容量低于正常范围的区域。我们相信我们的技术有可能在患者护理过程中改变游戏规则，因为大脑容量在疾病早期和疾病过程中都是医生感兴趣的，以监测大脑容量随着时间的推移在治疗期间“。

AIRAscore provides physicians with a clear narrative and pictogram showing absolute values with accurate volumes of tissues and brain areas, standardized to each individual's anatomy. It compares volumes of individual brain areas to a large reference population, corrected for head size, age, and sex, and presents the information in an easily understandable manner similar to a blood laboratory report.

AIRAscore为医生提供清晰的叙述和象形图，显示具有准确体积组织和大脑区域的绝对值，并根据每个人的解剖结构进行标准化。它将单个大脑区域的体积与大量参考人群进行比较，根据头部大小，年龄和性别进行校正，并以类似于血液实验室报告的易于理解的方式呈现信息。

Detailed information on the different lobes and limbic structures allows the identification of brain volumes that are not age appropriate, with different distribution patterns depending on the type of neurodegenerative disease. The technology therefore provides valuable information that supports physicians in the differentiated clarification of dementia forms, including Alzheimer’s Disease, frontotemporal dementia (FTD) as well as other dementias, movement disorders like atypical Parkinson syndromes and more diseases with known patterns of volume loss..

关于不同叶和边缘结构的详细信息允许识别不适合年龄的脑容量，根据神经退行性疾病的类型具有不同的分布模式。因此，该技术提供了有价值的信息，可支持医生对痴呆形式进行区分性澄清，包括阿尔茨海默氏病，额颞叶痴呆（FTD）以及其他痴呆症，运动障碍（如非典型帕金森综合征）和更多具有已知体积减少模式的疾病。。

AIRAscore also offers auto segmentation of grey matter, white matter, CSF, and T1 hypointensities and provides detailed measurements of all brain lobes, midbrain and pons, hippocampus, cerebellum, and ventricular systems to support radiologists, neurologists, and other physicians with further quantitative evidence in diagnosing a suspected dementia.

AIRAscore还提供灰质，白质，脑脊液和T1低信号的自动分割，并提供所有脑叶，中脑和脑桥，海马，小脑和心室系统的详细测量，以支持放射科医师，神经科医师和其他医生进一步定量诊断疑似痴呆症的证据。

The software is extremely affordable and can be configured by a hospital’s or radiology facility’s IT department in less than an hour..

该软件非常实惠，可以在不到一个小时的时间内由医院或放射设施的IT部门进行配置。。

“The innovative brain volumetry system AIRAscore offers new possibilities in diagnosis and treatment of neurodegenerative diseases with an easily accessible surrogate parameter of disease activity,” said Prof. Dr. Ahmed Othman, neuroradiologist, University Hospital Mainz, Germany. 'This is a big milestone for early detection, differential diagnostics and disease monitoring in dementias.'.

德国美因茨大学医院神经放射学家艾哈迈德·奥特曼博士说：“创新的脑容量测量系统AIRAscore为诊断和治疗神经退行性疾病提供了新的可能性，并具有易于获取的疾病活动替代参数。”这是痴呆症早期发现，鉴别诊断和疾病监测的一个重要里程碑。

AIRAscore has been used commercially in Europe for 4 years and will be available for purchase in the U.S. in the first quarter of 2024. Healthcare providers interested in demoing the software and learning more can contact info@airamed.de

AIRAscore已在欧洲商业化使用4年，并将于2024年第一季度在美国购买。有兴趣演示软件和学习更多信息的医疗保健提供者可以联系info@airamed.de

About AIRAmed

关于AIRAmed

AIRAmed is a medical technology company focused on the quantitative analysis of neuroradiological MRI image data. Its flagship product is AIRAscore, a medical image management and processing system providing relevant brain volumetry data to assist physicians in early detection of Alzheimer’s and other dementias..

AIRAmed是一家专注于神经放射学MRI图像数据定量分析的医疗技术公司。其旗舰产品是AIRAscore，医疗图像管理和处理系统，提供相关的脑容量数据，帮助医生早期发现阿尔茨海默氏症和其他痴呆症。。

AIRAscore uses deep learning and artificial intelligence (AI) technology to provide quantitative assessment of brain volume with objectively verifiable data using standard MRI brain scans in as little as five minutes.

AIRAscore使用深度学习和人工智能（AI）技术，在短短五分钟内使用标准MRI脑部扫描，通过客观可验证的数据提供脑容量的定量评估。

1 Chene G, Beiser A, Au R, Preis SR, Wolf PA, Dufouil C, et al. Gender and incidence of dementia in the Framingham Heart Study from mid-adult life. Alzheimers Dement 2015;11(3):310-20.

1 Chene G，Beiser A，Au R，Preis SR，Wolf PA，Dufouil C，et al。来自成年中期的Framingham心脏研究中痴呆的性别和发病率。阿尔茨海默氏症2015；11(3):310-20.