BOSTON--(BUSINESS WIRE)--Today, NuvoAir Medical announced its innovative Air Next Spirometer has received formal 510(k) clearance for in-home use as a full spirometer. 510(k) approval empowers NuvoAir to scale and expand clinical operations to ensure no patient with heart or lung conditions is left behind..

波士顿-（商业新闻）-今天，NuvoAir Medical宣布其创新的Air Next肺活量计已获得正式的510（k）许可，可在家用作全肺活量计。510（k）批准使NuvoAir能够扩大临床运营规模，以确保没有心脏或肺部疾病患者被留下。。

510(k) clearance allows Air Next to conduct full spirometry at home, providing extremely valuable clinical data that ensures patients can be monitored continuously. High-quality lung data empowers the NuvoAir clinical team to intervene when changes are detected and provide instantaneous care before lung function deteriorates to the point where hospitalizations are necessary.

510（k）清除率允许Air Next在家中进行全肺功能测定，提供极有价值的临床数据，确保患者可以连续监测。高质量的肺部数据使NuvoAir临床团队能够在检测到变化时进行干预，并在肺功能恶化至需要住院治疗之前提供即时护理。

For patients with conditions like COPD, Asthma, or ALS, using this easy-to-use device at home means they don’t have to wait for an in-person appointment or plan the logistics for travel..

对于患有COPD、哮喘或ALS等疾病的患者，在家使用这种易于使用的设备意味着他们不必等待亲自预约或计划旅行物流。。

“Air Next is capable of providing our care team with high-quality lung measurements from the comfort of our patients’ homes,” says Eric Harker, MD MPH MBA, and Chief Medical Officer at NuvoAir. “Spirometry has traditionally been underutilized as a diagnostic and monitoring tool because of the logistical challenges of getting complex patients to a clinic with regularity.

NuvoAir首席医疗官、医学博士、公共卫生硕士、工商管理硕士埃里克·哈克（EricHarker）表示：“Air Next能够在患者家中舒适地为我们的护理团队提供高质量的肺部测量。”。“传统上，肺活量测定法作为诊断和监测工具未得到充分利用，因为将复杂患者定期送往诊所面临后勤挑战。

In-home spirometry empowers our practice to provide continuous care to our patients in the home with real-time, high-quality, and actionable clinical data.”.

家庭肺活量测定法使我们的实践能够为家中的患者提供实时，高质量和可行的临床数据。”。

By achieving 510(k) clearance, the Air Next Spirometer can now be used for ATS 2019-compliant spirometry in clinical trials across the US and Europe. “Air Next brings the reliability of in-clinic spirometry right to our patients’ hands,” says Furat Shawki, General Manager of Clinical Trials at NuvoAir.

通过达到510（k）的清除率，Air Next肺活量计现在可以在美国和欧洲的临床试验中用于符合ATS 2019的肺活量测定。NuvoAir临床试验总经理Furat Shawki说：“Air接下来将临床肺活量测定的可靠性带到了患者的手中。”。

“With in-home approval of ATS 2019-compliant spirometry, we can look forward to scaling our services with our partners across the healthcare ecosystem, including healthcare providers and clinical trials, so we can deliver the cardiopulmonary care that people desperately deserve to the places that need it most.”.

“在国内批准符合ATS 2019标准的肺活量测定法后，我们可以期待与我们的合作伙伴在整个医疗保健生态系统（包括医疗保健提供者和临床试验）中扩展我们的服务，以便我们能够为最需要的地方提供人们迫切需要的心肺护理。”。

ABOUT NUVOAIR MEDICAL

关于NUVOAIR MEDICAL

NuvoAir Medical is a value-based specialty management platform transforming the diagnosis and management of chronic heart and lung conditions. NuvoAir’s care model integrates advanced monitoring technology and analytics with evidence-based interventions, all delivered by a multidisciplinary team. This approach ensures that each patient's journey is highly personalized.

NuvoAir Medical是一个基于价值的专业管理平台，可以改变慢性心肺疾病的诊断和管理。NuvoAir的护理模式将先进的监测技术和分析与循证干预相结合，所有这些都由多学科团队提供。这种方法确保每位患者的旅程高度个性化。

Collaborating with health plans and risk-bearing entities through flexible, value-based payment arrangements, NuvoAir distinguishes itself as a specialty care provider, effectively reducing healthcare costs and enhancing overall outcomes. For more information visit nuvoair.com..

通过灵活、基于价值的支付安排，NuvoAir与健康计划和风险承担实体合作，使其成为一家专业护理提供商，有效降低了医疗成本，提高了整体效果。有关更多信息，请访问nuvoair.com。。