护理点诊断技术开发商Analytics for Life和CorVista Health宣布CorVista系统肺动脉高压附加模块获FDA批准

AI辅助诊断技术提高了诊断准确率 #生活知识# #科技生活# #科技改变生活# #在线医疗#

Analytics for Life Inc. and CorVista Health Inc. have received U.S. Food and Drug Administration (FDA) clearance of the CorVista System with Pulmonary Hypertension (PH) Add-On Module. The CorVista System is reportedly the first FDA-cleared, machine learned point-of-care technology for indicating the likelihood of elevated mean arterial pulmonary pressure (mPAP), an indicator of pulmonary hypertension (PH)..

Analytics for Life Inc.和CorVista Health Inc.已获得美国食品和药物管理局（FDA）对带有肺动脉高压（PH）附加模块的CorVista系统的许可。据报道，CorVista系统是FDA批准的第一个机器学习的即时护理技术，用于指示平均动脉肺压（mPAP）升高的可能性，mPAP是肺动脉高压（PH）的指标。。

Pulmonary hypertension is a progressive disorder that affects the lung's blood vessels, causing the heart to work harder to deliver blood to the area. PH affects approximately 1% of the global population, and more than half of heart failure patients may be affected—the vast majority (80%) of whom live in areas with limited access to advanced cardiovascular medical and surgical care.

肺动脉高压是一种影响肺部血管的进行性疾病，导致心脏更加努力地将血液输送到该区域。PH影响全球约1%的人口，超过一半的心力衰竭患者可能受到影响，其中绝大多数（80%）生活在无法获得先进心血管医疗和外科护理的地区。

Despite advances in diagnostic technologies, PH is still often difficult to diagnose due to overlapping symptoms with other heart and lung conditions. Limited early detection and existing treatment options have contributed to increasing mortality rates for people living with PH, highlighting the need for continued diagnostic innovation.

尽管诊断技术取得了进展，但由于与其他心脏和肺部疾病的症状重叠，PH通常仍难以诊断。有限的早期发现和现有的治疗选择有助于提高PH患者的死亡率，突出了持续诊断创新的必要性。

The CorVista System with PH Add-On responds to this need, positioned to enable earlier diagnosis and better patient experiences in PH detection and treatment..

带有PH附加组件的CorVista系统响应了这一需求，能够在PH检测和治疗方面实现早期诊断和更好的患者体验。。

'As we continue to expand the CorVista System, we are proud to deliver advancements in diagnostics that support the earlier-stage detection of serious conditions, such as PH and CAD,' CorVista Health Vice President and General Manager Ian Shadforth said. 'Through CorVista, we are seeing how the power of machine learning can revolutionize care pathways, enabling earlier-stage detection and diagnosis, and ultimately empowering clinicians to deliver improved care and long-term outcomes.'.

科维斯塔健康副总裁兼总经理伊恩·沙德福斯（IanShadforth）说：“随着我们继续扩大科维斯塔系统，我们很自豪能够在诊断方面取得进步，支持对PH和CAD等严重疾病的早期检测。”通过CorVista，我们看到了机器学习的力量如何彻底改变护理途径，实现早期检测和诊断，并最终赋予临床医生更好的护理和长期结果。”。

The non-invasive CorVista System was recently cleared for use in evaluating the presence of significant coronary artery disease. In 2022 the FDA designated the CorVista System with PH Add-On as a Breakthrough Device for its potential to improve PH diagnosis. The breakthrough designation followed FDA’s review of a pilot performance study that demonstrated a reasonable expectation for the device to provide more effective diagnosis of PH in the standard of care.

非侵入性CorVista系统最近被批准用于评估是否存在严重的冠状动脉疾病。2022年，FDA将带有PH附加组件的CorVista系统指定为突破性设备，因为它具有改善PH诊断的潜力。FDA对一项试点性能研究进行了审查，该研究表明该设备可以在护理标准中提供更有效的PH诊断，这一突破性的指定是在FDA对该试验性能研究进行审查之后进行的。

Results of the extensive clinical validation study supporting the market application (IDENTIFY PH) showed algorithm performance in identifying patients with elevated mPAP with 82% sensitivity and 92% specificity with a >99% negative predictive value (NPV). Introduction of the PH indication to the CorVista System will allow healthcare providers to test symptomatic patients for multiple significant cardiovascular conditions in a single non-invasive procedure at the initial point of care.

支持市场应用的广泛临床验证研究（IDENTIFY PH）的结果显示，算法在识别mPAP升高的患者方面表现出82%的敏感性和92%的特异性，阴性预测值（NPV）>99%。将PH指示引入CorVista系统将允许医疗保健提供者在初始护理点通过单一的非侵入性程序测试有症状患者的多种重要心血管疾病。

Having received market clearance, the CorVista System with PH Add-On joins a small cohort of less than 100 breakthrough-designated devices to enter the U.S. market. .

在获得市场许可后，带有PH插件的CorVista系统加入了不到100个突破性指定设备的小组，进入美国市场。。

'Through the CorVista System, we have harnessed the potential of machine learning to develop our detection algorithms and deliver precise and reliable diagnostic tools,” Analytics for Life Chief Technology Officer/General Manager Jonathan Woodward stated. “The Pulmonary Hypertension Add-On underscores our dedication to advancing solutions that make a tangible difference in patients' lives.”.

“通过CorVista系统，我们利用了机器学习的潜力来开发我们的检测算法，并提供精确可靠的诊断工具，”生命分析首席技术官/总经理乔纳森·伍德沃德表示。“肺动脉高压的增加突显了我们致力于推进解决方案，从而为患者的生活带来切实的改变。”。

Analytics For Life will continue to partner with CorVista Health to commercialize the CorVista System within the United States.

Analytics For Life将继续与CorVista Health合作，在美国将CorVista系统商业化。

'I can't emphasize the importance of early diagnosis enough,” said Vallerie V. McLaughlin, M.D., the Kim A. Eagle M.D. Endowed Professor of Cardiovascular Medicine, director of Pulmonary Hypertension at the University of Michigan Ann Arbor, and CorVista Health Medical Advisory Board member. “This technology has the potential to really improve the time from symptoms to diagnosis.'.

“我再怎么强调早期诊断的重要性也不为过，”医学博士Vallerie V.McLaughlin说，他是Kim A.Eagle医学博士授予的心血管医学教授、密歇根大学安阿伯分校肺动脉高压主任和CorVista健康医学顾问委员会委员。“这项技术有可能真正缩短从症状到诊断的时间。”。

Pulmonary hypertension is challenging to diagnose, affecting an estimated 1% of the world population and up to 10% of people greater than 65 years of age as well as 50% of patients with heart failure. The vast majority of those persons with this disorder (80%) live in areas with limited access to appropriate medical and surgical care.

肺动脉高压的诊断具有挑战性，估计影响世界人口的1%，高达10%的65岁以上人群以及50%的心力衰竭患者。绝大多数患有这种疾病的人（80%）生活在获得适当医疗和外科护理的机会有限的地区。

Pulmonary arterial hypertension is an aggressive disease resulting in right ventricular pressure/volume overload, right ventricular failure, and, in many cases, early death..

肺动脉高压是一种侵袭性疾病，会导致右心室压力/容量超负荷，右心室衰竭，在许多情况下还会导致早期死亡。。

The CorVista System is a prescription only, non-invasive point-of-care solution intended to synchronously collect and apply machine learning to a symptomatic patient's cardiac and hemodynamic signals to predict the likelihood of cardiovascular diseases without the use of radiation, contrast agents, injections, fasting, or exercise.

CorVista系统是一种仅限处方的非侵入性即时护理解决方案，旨在同步收集有症状患者的心脏和血流动力学信号并将机器学习应用于预测心血管疾病的可能性，而无需使用辐射，造影剂，注射，禁食或运动。

Within minutes of the test, the CorVista Analysis is available in a secure web portal to help physicians diagnose and treat patients with suspected cardiovascular disease. The CorVista System is developed and manufactured by Analytics For Life Inc. and licensed to CorVista Health Inc..

在测试几分钟内，CorVista分析可以在一个安全的门户网站上获得，以帮助医生诊断和治疗疑似心血管疾病的患者。CorVista系统由Analytics For Life Inc.开发和制造，并授权给CorVista Health Inc。。

Headquartered in Toronto, Analytics For Life specializes in non-invasive diagnostic solutions for cardiovascular diseases through the CorVista System. The CorVista System offers a non-invasive, point-of-care solution to assess symptomatic patients for cardiovascular disease without radiation, contrast agents, injections, fasting, or exercise. .

总部位于多伦多的Analytics For Life专门通过CorVista系统为心血管疾病提供非侵入性诊断解决方案。CorVista系统提供了一种非侵入性的即时护理解决方案，用于评估有症状的患者的心血管疾病，无需辐射，造影剂，注射，禁食或运动。。

CorVista Health Inc. is applying machine learning to deliver cardiac disease detection algorithms using the proprietary CorVista System platform to transform cardiovascular care and the patient experience.

CorVista Health Inc.正在应用机器学习，使用专有的CorVista系统平台提供心脏病检测算法，以改变心血管护理和患者体验。

网址：护理点诊断技术开发商Analytics for Life和CorVista Health宣布CorVista系统肺动脉高压附加模块获FDA批准 https://www.yuejiaxmz.com/news/view/1230594

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