Two years after its launch as a joint venture between the Mayo Clinic and Nference to develop artificial intelligence algorithms capable of pulling out new insights from routine electrocardiogram results, Anumana has earned its first 510(k) clearance from the FDA for one of those tools.

Anumana是梅奥诊所（Mayo Clinic）和Nference（Nference）的合资企业，旨在开发能够从常规心电图结果中获得新见解的人工智能算法，两年后，Anumana首次获得FDA对其中一种工具的510（k）许可。

The ECG-AI LEF algorithm was crafted to analyze the peaks and valleys of a 12-lead ECG scan to spot the signs of low ejection fraction in patients with a heightened risk of heart failure. Ejection fraction measures the heart’s ability to effectively pump blood throughout the body, so a lower measurement can indicate the presence of heart failure, potentially leading to cardiac arrest or other life-threatening complications..

ECG-AI LEF算法是为了分析12导联心电图扫描的峰谷，以发现心力衰竭风险较高的患者射血分数低的迹象。射血分数测量心脏有效泵血全身的能力，因此较低的测量值可能表明存在心力衰竭，可能导致心脏骤停或其他危及生命的并发症。。

Low ejection fraction is typically diagnosed using ultrasound, but Anumana’s tool aims to replace that approach with an automated analysis of faster, simpler, and less expensive ECG scans. Other diagnostic tools include CT, MRI and nuclear medicine scans and a more invasive approach known as cardiac catheterization..

低射血分数通常使用超声波诊断，但Anumana的工具旨在用更快，更简单，更便宜的ECG扫描自动分析来替代这种方法。其他诊断工具包括CT、MRI和核医学扫描，以及一种更具侵入性的方法，即心导管插入术。。

“Anumana’s ECG-AI LEF fills an important unmet need—the lack of an easily accessible point-of-care, noninvasive, and inexpensive tool to screen for a weak heart pump,” Paul Friedman, M.D., chair of the Mayo Clinic’s cardiovascular medicine department and chair of Anumana’s board of advisors, said in a company announcement this week.

“Anumana的ECG-AI LEF填补了一个重要的未满足需求，即缺乏一个易于获得的护理点，无创且廉价的工具来筛查心脏泵功能较弱，”梅奥诊所心血管医学系主任兼Anumana顾问委员会主席Paul Friedman医学博士在本周的公司公告中表示。

“It allows identification of otherwise hidden disease, for which many effective, lifesaving treatments are available—once the presence of the disease is known.”.

“它可以识别其他隐藏的疾病，一旦知道疾病的存在，就可以进行许多有效的挽救生命的治疗。”。

The ECG-AI LEF algorithm was originally developed at the Mayo Clinic, using paired ECG and echo data from tens of thousands of patients.

ECG-AI LEF算法最初是在梅奥诊所开发的，使用来自数万名患者的成对ECG和回声数据。

It has since been put to the test in more than two dozen studies, including a retrospective analysis of 16,000 racially diverse patients in which the AI was able to detect instances of low ejection fraction with nearly 85% sensitivity and weed out negative cases with about 84% specificity, according to Anumana..

自那以后，它已经在二十多项研究中进行了测试，其中包括对16000名不同种族的患者进行的回顾性分析，根据Anumana的说法，AI能够以近85%的敏感性检测出低射血分数的情况，并剔除约84%特异性的阴性病例。。

Separately, in a clinical trial that spanned more than 22,000 adults receiving routine clinical care at 45 clinics and hospitals, investigators concluded that using the algorithm helped improve clinicians’ ability to accurately diagnose low ejection fraction by 31% compared to the standard of care, with no increase in echo usage.

另外，在一项涵盖45家诊所和医院接受常规临床护理的22000多名成年人的临床试验中，研究人员得出结论，与标准护理相比，使用该算法有助于提高临床医生准确诊断低射血分数的能力31%，回声使用率没有增加。

The study’s researchers noted that the AI had been able to find additional cases of low ejection fraction that may have otherwise gone overlooked, using only ECG data already sitting in patients’ electronic health records..

该研究的研究人员指出，人工智能仅使用患者电子健康记录中已有的心电图数据，就能够发现其他可能被忽视的低射血分数病例。。

Though the 510(k) clearance announced this week occurred on Anumana’s watch, the ECG-AI LEF algorithm’s history with the FDA dates back well before the Fierce 15 honoree was even established. For one, in 2019, while still fully under the Mayo Clinic’s purview, it earned breakthrough device clearance from the agency, clearing away some obstacles on its path to full clearance..

虽然本周宣布的510（k）许可证是在Anumana的手表上宣布的，但ECG-AI LEF算法在FDA的历史可以追溯到这位15岁的获奖者成立之前。例如，2019年，虽然仍完全在梅奥诊所的管辖范围内，但它获得了该机构突破性的设备许可，扫清了通往完全许可的道路上的一些障碍。。

Then, in the early months of the COVID-19 pandemic in 2020, while the algorithm was licensed to smart stethoscope maker Eko Health, it scored an emergency use authorization from the FDA, enabling it to help spot signs of a weakening heart pump in patients hospitalized with COVID, which can exacerbate cardiovascular issues..

然后，在2020年新型冠状病毒肺炎大流行的前几个月，虽然该算法被授权给智能听诊器制造商Eko Health，但它获得了FDA的紧急使用授权，使其能够帮助发现住院治疗新型冠状病毒的患者心脏泵减弱的迹象，这可能会加剧心血管问题。。