With planned market expansion following the FDA clearance, the company is establishing a US headquarters in Jersey City.
Synchrony Medical, a medical technology focused on respiratory care, has received US Food and Drug Administration (FDA) 510(k) clearance to market its LibAirty Airway Clearance System in the United States.
The LibAirty System is designed to address a need for patients with chronic lung diseases such as chronic obstructive pulmonary disease, bronchiectasis, and cystic fibrosis.
The system works by synchronizing controlled breathing with targeted chest compressions. Developed in collaboration with experts from the Sheba Medical Center, this technology is inspired by the principles of autogenic drainage, an airway clearance technique that typically requires extensive patient training and support from a respiratory therapist, according to a news release from the company. LibAirty adapts this technique with a patient app that provides breathing guidance and a wearable vest that delivers synchronized chest compressions.
Clinical studies conducted at the Medical University of South Carolina and Sheba Medical Center demonstrated that LibAirty was twice as effective compared to traditional vest-based therapy, alongside higher user satisfaction scores.
“Our study demonstrated that LibAirty has the potential to enhance clinical outcomes for a significant group of patients,” says Patrick Flume, MD, pulmonologist and director of the Adult Cystic Fibrosis Center at MUSC Health, in a release. “I am excited to have LibAirty as a solution for those who need effective airway clearance at home.”
“Receiving FDA clearance for LibAirty is a pivotal moment in our mission to transform respiratory care,” says Anat Shani, Synchrony Medical CEO, in a release. “This milestone will allow us to help improve patients’ lives and overall respiratory health.”
The Israel-based company is now establishing a US headquarters in New Jersey and is preparing for a limited rollout of LibAirty in select sites later in 2025.
Photo caption: LibAirty Airway Clearance System
Photo credit: Synchrony Medical
