Israel-based medical technology firm Synchrony Medical has received the US Food and Drug Administration (FDA) 510(k) clearance for its LibAirty Airway Clearance System for at-home respiratory relief.
The system is designed to assist individuals with chronic lung diseases, including chronic obstructive pulmonary disease (COPD), bronchiectasis, and cystic fibrosis.
Synchrony Medical co-founder and Sheba Medical Center senior paediatric pulmonologist Dr Moshe Ashkenazi said: “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 hospitalisations.
“Unfortunately, many patients still lack access to effective airway clearance solutions they can use routinely at home.”
Unlike traditional methods, LibAirty synchronises controlled breathing with targeted chest compressions, offering a clinically proven method for superior airway clearance.
Clinical trials at the Medical University of South Carolina and Sheba Medical Center have shown that LibAirty is twice as effective as conventional vest-based therapies, with improved user satisfaction.
The technology behind LibAirty, developed in collaboration with Sheba Medical Center experts, draws from the principles of Autogenic Drainage. This established airway clearance technique usually requires significant patient training and respiratory therapist support.
LibAirty simplifies this process through a patient app that offers breathing guidance and a wearable vest that delivers synchronised chest compressions. This combination effectively directs airflow to clear even the smallest airways.
Synchrony Medical CEO Anat Shani said: “Receiving FDA clearance for LibAirty is a pivotal moment in our mission to transform respiratory care.
“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.”
Following the FDA clearance, Synchrony Medical plans to expand its reach and establish partnerships to distribute LibAirty to patients throughout the US.
