/PRNewswire/ -- Synchrony Medical, a medical technology company dedicated to advancing respiratory care, today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance to market its LibAirty

/PRNewswire/ -- 致力于推进呼吸护理的医疗技术公司Synchrony Medical今天宣布，已获得美国食品药品监督管理局（FDA）510(k)许可，可以将其LibAirty产品上市。

Airway Clearance System in

气道清除系统

The LibAirty System addresses a critical need for patients living with chronic lung diseases such as chronic obstructive pulmonary disease (COPD), bronchiectasis, and cystic fibrosis. 'For millions of people, effective airway clearance is vital for reducing symptoms, improving quality of life, slowing disease progression, and preventing infections that often lead to costly hospitalizations.

LibAirty系统满足了慢性肺病患者的关键需求，如慢性阻塞性肺病（COPD）、支气管扩张症和囊性纤维化。对数百万人而言，有效的气道清除对于减轻症状、提高生活质量、减缓疾病进展以及预防常导致昂贵住院费用的感染至关重要。

Unfortunately, many patients still lack access to effective airway clearance solutions they can use routinely at home,' explains Dr. Moshe Ashkenazi, co-founder of Synchrony Medical and Senior Pediatric Pulmonologist at Sheba Medical Center..

“不幸的是，许多患者仍然无法在家中常规使用有效的气道清除解决方案，”舍巴医疗中心高级儿科肺病学家、Synchrony Medical联合创始人莫什·阿什肯纳齐博士解释道。

LibAirty is the first airway clearance system that synchronizes controlled breathing with targeted chest compressions – offering clinically-proven superior airway clearance. Clinical studies conducted at the

LibAirty 是首个将受控呼吸与针对性胸部按压同步进行的气道清除系统——提供经临床验证的卓越气道清除效果。在

Medical University of South Carolina

南卡罗来纳医科大学

(MUSC) and Sheba Medical Center demonstrated that LibAirty was twice as effective compared to traditional vest-based therapy, alongside higher user satisfaction scores.

(MUSC) 和 Sheba 医疗中心的试验表明，LibAirty 的效果是传统背心疗法的两倍，且用户满意度评分更高。

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'Our study demonstrated that LibAirty has the potential to enhance clinical outcomes for a significant group of patients,' comments Dr. Patrick Flume, pulmonologist and director of the Adult Cystic Fibrosis Center at MUSC Health. 'I am excited to have LibAirty as a solution for those who need effective airway clearance at home.'.

“我们的研究表明，LibAirty 有潜力改善一大部分患者的临床结果，”MUSC Health 成人囊性纤维化中心主任、肺科医生帕特里克·弗卢姆博士评论道。“我很高兴能将 LibAirty 作为那些需要在家中进行有效气道清除的患者的解决方案。”

Developed in collaboration with experts from the Sheba Medical Center, LibAirty's technology is inspired by the principles of Autogenic Drainage, a proven airway clearance technique that typically requires extensive patient training and support from a respiratory therapist. LibAirty adapts this technique with a patient app that provides breathing guidance and a wearable vest that delivers synchronized chest compressions, directing airflow to thoroughly clear even the hardest-to-reach small airways..

与来自谢巴医疗中心的专家合作开发的LibAirty技术受到了自体引流原理的启发，这是一种已被证实的气道清除技术，通常需要对患者进行大量培训，并由呼吸治疗师提供支持。LibAirty通过一款为患者提供呼吸指导的应用程序和一件提供同步胸部按压的可穿戴背心来实现这一技术，引导气流彻底清除最难到达的小气道。

'Receiving FDA clearance for LibAirty is a pivotal moment in our mission to transform respiratory care,' said

“LibAirty获得FDA批准是我们实现转变呼吸系统护理使命的关键时刻，”

Anat Shani

阿纳特·沙尼

, Synchrony Medical CEO. 'This milestone will allow us to help improve patients' lives and overall respiratory health. Building on this achievement, we are establishing our US headquarters in

，Synchrony Medical首席执行官。“这一里程碑将使我们能够帮助改善患者的生活和整体呼吸健康。在此成就的基础上，我们正在美国设立总部。

New Jersey

新泽西州

and are actively preparing for a limited rollout of LibAirty in select sites later in 2025,' she adds.

并且正在积极准备在 2025 年晚些时候在部分地点有限度地推出 LibAirty，”她补充道。

With FDA clearance secured, Synchrony Medical is now focused on scaling its solution and forging partnerships to bring LibAirty to patients across the U.S.

随着FDA审批的通过，Synchrony Medical现在专注于扩展其解决方案并建立合作关系，以将LibAirty带给全美的患者。

About Synchrony Medical

关于Synchrony Medical

Synchrony Medical is a medical technology company dedicated to transforming respiratory care. Based on innovative technology developed with the Sheba Medical Center, our mission is to ensure that advanced, expert-level respiratory care is accessible to patients worldwide. Synchrony Medical is based in .

Synchrony Medical是一家致力于改变呼吸护理的医疗技术公司。基于与示巴医疗中心共同开发的创新技术，我们的使命是确保全球患者都能获得先进、专家级的呼吸护理。Synchrony Medical总部位于。