BOSTON--(BUSINESS WIRE)--AISAP, a medical technology company developing AI-powered Point-of-Care Assisted Diagnosis (POCAD™) solutions to transform medical ultrasound, has announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its first-of-a-kind, AI-powered AISAP CARDIO point-of-care ultrasound (POCUS) software platform.

波士顿--（商业新闻短讯）--AISAP是一家医疗技术公司，开发人工智能辅助诊断（POCAD™）解决方案来改造医疗超声波，该公司宣布，美国食品和药物管理局（FDA）已批准510（k）许可其首款人工智能辅助的AISAP心脏超声（POCUS）软件平台。

The cloud-based platform combines four computer-assisted diagnosis (CADx) modules of valvular pathologies and eight key measurements into a single, comprehensive, cardiac ultrasound software package that automatically generates analyses, interpretations and reports. CARDIO empowers clinicians with basic scanning skills to accurately diagnose up to 90 percent of the most common cardiac structural and functional parameters right at the bedside within minutes..

基于云的平台将瓣膜病变的四个计算机辅助诊断（CADx）模块和八个关键测量结合到一个单一的，全面的心脏超声软件包中，该软件包自动生成分析，解释和报告。CARDIO使具有基本扫描技能的临床医生能够在几分钟内准确诊断床边最常见的心脏结构和功能参数的90%。。

“AISAP CARDIO has the potential to be a game-changer in the world of point-of-care ultrasound,” said Smadar Kort, MD, system director of Non Invasive Cardiac Imaging, Stony Brook Medicine, and past governor of the American College of Cardiology. “We know that structural heart disease and heart failure are the leading causes of hospitalization and morbidity in the U.S.

“AISAP CARDIO有可能成为即时超声波领域的游戏规则改变者，”史东溪医学院无创心脏成像系统主任、美国心脏病学会前任理事Smadar Kort医学博士说。“我们知道结构性心脏病和心力衰竭是美国住院和发病的主要原因。

Enabling a wide variety of qualified physicians to quickly and accurately diagnose these conditions at the bedside could lead to earlier detection and treatment, and better patient outcomes, as well as greater efficiencies and cost savings to health systems, while ultimately saving countless lives.”.

使各种合格的医生能够在床边快速准确地诊断这些疾病，可以更早地发现和治疗，改善患者预后，提高卫生系统的效率和成本节约，同时最终挽救无数生命。”。

AISAP CARDIO is indicated to provide diagnostic assessment and measurements of several key cardiac structural functional parameters, including: presence of valvular pathology (regurgitations of the mitral, tricuspid, aortic valves and aortic stenosis), and measurements of left ventricle ejection fraction (LVEF), right and left ventricular dimensions, right ventricular fractional area change (RV FAC), atrial areas, ascending aorta diameter, and inferior vena cava (IVC) diameter..

AISAP CARDIO可提供几个关键心脏结构功能参数的诊断评估和测量，包括：瓣膜病理（二尖瓣，三尖瓣，主动脉瓣和主动脉瓣狭窄的反流）的存在，以及左心室射血分数（LVEF）的测量，左右心室尺寸，右心室分数面积变化（RV FAC），心房面积，升主动脉直径和下腔静脉（IVC）直径。。

The platform is designed to generate reliable and validated assessments early in the patient evaluation process and whenever needed during the course of therapy. It is a vendor-agnostic, scalable solution that seamlessly integrates into the clinical workflow, as well as existing EHR/EMR and PACS systems.

该平台旨在在患者评估过程的早期以及治疗过程中需要时产生可靠且经过验证的评估。它是一种与供应商无关的可扩展解决方案，可无缝集成到临床工作流程以及现有的EHR/EMR和PACS系统中。

The software generates accurate reports in minutes using inexpensive devices, enabling emergency medicine, critical care, internal medicine, hospitalists and primary care physicians to make informed care decisions at the bedside. Prospective data have shown that use of CARDIO has generated improvement in clinician performance, with care pathway changes in one third of scanned patients.1 The platform also offers telemedicine, cloud computing and education tools..

该软件使用廉价的设备在几分钟内生成准确的报告，使急诊医学，重症监护，内科，住院医生和初级保健医生能够在床边做出明智的护理决策。前瞻性数据显示，有氧运动的使用改善了临床医生的表现，三分之一的扫描患者的护理路径发生了变化。1该平台还提供远程医疗，云计算和教育工具。。

“AISAP CARDIO was developed by top-notch technologists and cardiologists to close critical gaps in patient care. Our ‘anywhere, anytime AI’ approach is aimed at transforming healthcare by bringing cutting-edge diagnostic tools to the point of care,” said Adiel Am-Shalom, CEO, AISAP.

“AISAP CARDIO 由一流的技术专家和心脏病专家共同开发，旨在弥补患者护理中的关键差距。我们的'随时随地的人工智能'方法旨在通过将最先进的诊断工具带到护理点来改变医疗保健，"爱沙普首席执行官Adiel Am-Shalom说。

“This milestone makes AISAP the first company in the world to secure FDA clearance in the CADx pathway for the comprehensive diagnosis of structural heart diseases using POCUS. It marks a big step in our goal of delivering point-of-care assisted diagnosis, or POCAD, with unparalleled scalability and accessibility – from the largest academic centers to the most remote rural locations,” added Ehud Raanani, MD, co-founder, AISAP, and director, Leviev Cardiovascular and Thoracic Center, Sheba Medical Center..

“这一里程碑使AISAP成为世界上第一家通过CADx途径获得FDA批准的公司，用于使用POCUS对结构性心脏病进行全面诊断。这标志着我们在提供护理点辅助诊断（POCAD）的目标上迈出了一大步，POCAD具有无与伦比的可扩展性和可访问性-从最大的学术中心到最偏远的农村地区，”AISAP联合创始人兼Sheba医学中心Leviev心血管和胸腔中心主任Ehud Raanani医学博士补充道。。

CARDIO was trained on hundreds of thousands of studies comprising over 24 million echo video clips. AISAP’s novel algorithms on POCUS devices has been validated in multi-national, multi-site, randomized, multi-reader, multi-case clinical trials at Mass General Brigham, Thomas Jefferson University Hospital, Mayo Clinic, Inova Fairfax Medical Campus, Crozer-Chester Medical Center and Stony Brook University Hospital..

CARDIO接受了数十万项研究的培训，其中包括2400多万个echo视频剪辑。AISAP在POCUS设备上的新算法已在Mass General Brigham、Thomas Jefferson University Hospital、Mayo Clinic、Inova Fairfax Medical Campus、Crozer Chester Medical Center和Stony Brook University Hospital的多国、多地点、随机、多读者、多病例临床试验中得到验证。。

The accuracy and impact of the novel CARDIO algorithms on POCUS cases were shown in standalone model performance and clinical reader performance studies led by Dr. James Hillis, MBBS, DPhil, director of Clinical Operations at Mass General Brigham AI. Data from the studies demonstrated that AISAP CARDIO enables non-cardiologist physicians to interpret point-of-care echocardiograms just as well as expert cardiologists of the MGB echocardiography lab.

Mass General Brigham AI临床运营总监James Hillis博士（MBBS，DPhil）领导的独立模型性能和临床读者性能研究显示了新型心脏算法对POCUS病例的准确性和影响。研究数据表明，AISAP CARDIO使非心脏病医生能够像MGB超声心动图实验室的专家心脏病专家一样解释即时超声心动图。

That testing demonstrated that measures performed by the AISAP CARDIO device were as close or even frequently closer to the mean of 3 MGB cardiologists than each individual cardiologist.2 Standalone performance for significant major valve disease pathology (aortic stenosis and regurgitation and mitral and tricuspid regurgitation) had a 93 percent sensitivity and 93 percent specificity.2.

该测试表明，AISAP心脏设备进行的测量结果与每位心脏病专家的平均值一样接近甚至更接近3名MGB心脏病专家的平均值。2重要的主要瓣膜疾病病理（主动脉瓣狭窄和反流以及二尖瓣和三尖瓣反流）的独立表现具有93%的敏感性和93%的特异性。

“We assessed the device’s performance for two key tasks: the calculation of eight cardiac measurements and the interpretation of four valvular pathologies,” said Dr. Hillis. “The results demonstrated that the use of the device improved the accuracy of physicians in interpreting the valvular pathologies.”.

Hillis博士说：“我们评估了该设备在两项关键任务中的性能：计算八个心脏测量值和解释四个瓣膜病变。”。“结果表明，该设备的使用提高了医生解释瓣膜病变的准确性。”。

CARDIO will be available for commercial use on September 1. Please visit www.aisap.ai for more information or to book a demo.

CARDIO将于9月1日投入商业使用。请访问www.aisap.ai了解更多信息或预订演示。

About AISAP

关于AISAP

AISAP LTD is a pioneering company at the intersection of artificial intelligence and healthcare with a mission to transform healthcare delivery through its flagship product, AISAP CARDIO, which for the first time delivers POCAD™ (Point-of-Care Assisted Diagnosis). The platform enables clinicians to perform comprehensive, AI-powered ultrasound diagnostics anywhere, anytime, ensuring that advanced medical care is accessible at the patient’s bedside, whether in a hospital, clinic or rural setting..

AISAP有限公司是人工智能和医疗保健交叉点的一家开创性公司，其使命是通过其旗舰产品AISAP CARDIO转变医疗保健服务，AISAP CARDIO首次提供POCAD™（护理点辅助诊断）。该平台使临床医生能够随时随地进行全面的人工智能超声波诊断，确保无论是在医院、诊所还是在农村地区，患者床边都可以获得先进的医疗保健。。

AISAP’s intuitive and secure SaaS platform is designed to empower healthcare providers by streamlining diagnosis processes, enhancing clinical efficiency, and improving patient outcomes.

AISAP直观而安全的SaaS平台旨在通过简化诊断流程，提高临床效率和改善患者预后来增强医疗保健提供者的能力。