Synchrony Medical Receives 510(k) FDA Clearance for LibAirty™ Airway Clearance System for At-Home Respiratory Relief

With Planned Market Expansion Following FDA Milestone, Company Establishes U.S. Headquarters in Jersey City

JERSEY CITY, N.J. and OR YEHUDA, Israel, July 10, 2025 /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™ Airway Clearance System in the United States.

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. 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]

"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."

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," she adds.

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.

About 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.

For more information, visit https://libairty.health. 

Photo: https://mma.prnewswire.com/media/2728679/Synchrony_Medical_LibAirty_Airway.jpg

Media Contact:
Eileen Ke
eileen.ke@synchrony-medical.com
+1-800-590-1807

View original content to download multimedia:https://www.prnewswire.com/news-releases/synchrony-medical-receives-510k-fda-clearance-for-libairty-airway-clearance-system-for-at-home-respiratory-relief-302502345.html

SOURCE Synchrony Medical