Synchrony Medical Receives FDA 510(k) Clearance for LibAirty Airway Clearance System
核心洞察
Synchrony Medical (搜索) has received FDA 510(k) clearance for its LibAirty (搜索) Airway Clearance System, marking the first device to synchronize controlled breathing with targeted chest compressions for respiratory care.
Clinical studies at Medical University of South Carolina and Sheba Medical Center demonstrated that LibAirty (搜索) was twice as effective compared to traditional vest-based therapy for patients with chronic lung diseases.
The system addresses critical needs for patients with COPD, bronchiectasis, and cystic fibrosis by providing effective at-home airway clearance solutions to reduce symptoms and prevent costly hospitalizations.
Synchrony Medical (搜索) announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance to market its LibAirty (搜索)™ Airway Clearance System in the United States. The medical technology company, which focuses on advancing respiratory care, achieved this regulatory milestone as it prepares to establish its U.S. headquarters in Jersey City, New Jersey.
Revolutionary Airway Clearance Technology
The LibAirty (搜索) System represents a significant advancement in respiratory care, being the first airway clearance system that synchronizes controlled breathing with targeted chest compressions. This innovative approach addresses critical needs for patients living with chronic lung diseases including 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," explains Dr. Moshe Ashkenazi, co-founder of Synchrony Medical (搜索) and Senior Pediatric Pulmonologist at Sheba Medical Center. "Unfortunately, many patients still lack access to effective airway clearance solutions they can use routinely at home."
Clinical Evidence Demonstrates Superior Efficacy
Clinical studies conducted at the Medical University of South Carolina (MUSC) and Sheba Medical Center provided compelling evidence of LibAirty (搜索)'s effectiveness. The research demonstrated that LibAirty was twice as effective compared to traditional vest-based therapy, while also achieving higher user satisfaction scores.
"Our study demonstrated that LibAirty (搜索) 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."
Technology Inspired by Proven Techniques
Developed in collaboration with experts from the Sheba Medical Center, LibAirty (搜索)'s technology draws inspiration from the principles of Autogenic Drainage, a proven airway clearance technique that typically requires extensive patient training and support from a respiratory therapist. The system adapts this technique through 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.
Market Expansion and Commercial Plans
"Receiving FDA clearance for LibAirty (搜索) is a pivotal moment in our mission to transform respiratory care," said Anat Shani, Synchrony Medical (搜索) 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 (搜索) is now focused on scaling its solution and forging partnerships to bring LibAirty (搜索) to patients across the U.S. The company's dual headquarters approach, with locations in Jersey City, New Jersey and Or Yehuda, Israel, positions it to serve both American and international markets as it works to make advanced respiratory care accessible to patients worldwide.