Synchrony Medical’s new LibAirty Airway Clearance System has been cleared in the United States as the company prepares for a limited rollout in 2025 from its new US company headquarters in New Jersey.
RT’s Three Key Takeaways:
- FDA Clearance: Synchrony Medical’s LibAirty Airway Clearance System has received FDA 510(k) clearance, enabling its market entry in the US for patients with chronic lung diseases.
- Innovative Technology: LibAirty combines synchronized chest compressions with guided breathing via an app, offering airway clearance that clinical studies show is twice as effective as traditional vest therapy.
- Patient Accessibility: Designed for home use, LibAirty aims to expand access to effective, user-friendly respiratory care, with a limited US rollout planned for late 2025.
Synchrony Medical has received US FDA 510(k) clearance to market its LibAirty Airway Clearance System in the United States, according to a company news release.
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. 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.
LibAirty is the first airway clearance system that synchronizes controlled breathing with targeted chest compressions, offering clinically-proven superior airway clearance, according to Synchrony Medical. Clinical studies conducted at the Medical University of South Carolina (MUSC) and Sheba Medical Center demonstrated that LibAirty was twice as effective compared to traditional vest-based therapy, alongside higher user satisfaction scores.1-2
“Our study demonstrated that LibAirty has the potential to enhance clinical outcomes for a significant group of patients,” said 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.”
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.
“Receiving FDA clearance for LibAirty is a pivotal moment in our mission to transform respiratory care,” said Anat Shani, 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 New Jersey and are actively preparing for a limited rollout of LibAirty in select sites later in 2025.”
With FDA clearance secured, Synchrony Medical is now focused on scaling its solution and forging partnerships to bring LibAirty to patients across the US, the company says.
References and Notes from 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 Jersey City, New Jersey (SciTech Scity), and Or Yehuda, Israel.
- Helper N, Ashkenazi M, Sokol G, Dagan A, Efrati O. A Novel Medical Device for Airway Clearance. J Clin Med. 2025 Jan 30;14(3):907.
- Mingora C, Barfield W, Shani A, Tzfoni T, Flume P. Evaluation of the Safety and Efficacy of LibAirtyTM Airway Clearance System in Patients with Bronchiectasis. Presented at The American College of Chest Physicians (CHEST) Annual Meeting 2023.
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