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

Pioneered at Sheba Medical Center, Wearable Device Shows Enhanced Effectiveness to Traditional Vest-Based Therapy for Chronic Lung Disease Patients

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

JERSEY CITY, New Jersey and OR YEHUDA, Israel – July 10, 2025 – 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^TM Airway Clearance System in the United States.

The LibAirty System addresses a critical need for the millions of patients living with chronic lung diseases such as chronic obstructive pulmonary disease (COPD), bronchiectasis, and cystic fibrosis by enabling effective airway clearance, which reduces symptoms, improves quality of life, slows disease progression, and prevents infections that often lead to costly hospitalizations. 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

“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.”

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.

As part of Sheba’s ARC innovation center’s ecosystem, Synchrony exemplifies the fusion of clinical insight, academic rigor, and entrepreneurial agility that defines ARC’s mission to transform global health.

“Synchrony’s achievement is yet another testament to the unique synergy that defines the ARC ecosystem—where deep understanding of patient care, cutting-edge technology, and entrepreneurial drive converge”, said Prof. Eyal Zimlichman, Founder and Director of ARC, and Chief Innovation, Transformation, and AI Officer at Sheba Medical Center. “LibAirtyTM is a patient-centered, clinically grounded response to a long-standing unmet need in chronic respiratory care, expanding our portfolio of high-impact, real-world solutions that truly transform patient care.”

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/.