#United States #Jersey City #COPD #LibAirty #Synchrony Medical

Synchrony Medical Secures FDA Clearance for LibAirty™

Synchrony Medical, a company at the forefront of medical technology, has announced a significant milestone in respiratory care with the FDA's 510(k) clearance of its LibAirty™ Airway Clearance System. This innovative device caters to the pressing need for effective home airway clearance solutions, especially for patients suffering from chronic lung diseases like chronic obstructive pulmonary disease (COPD), bronchiectasis, and cystic fibrosis.

Dr. Moshe Ashkenazi, the co-founder of Synchrony Medical and a senior pediatric pulmonologist at Sheba Medical Center, highlights the crucial role of effective airway clearance in improving patients' lives. He remarks, "For millions of people, effective airway clearance is vital for reducing symptoms, improving quality of life, slowing disease progression, and preventing infections that often necessitate costly hospitalizations. Unfortunately, many patients still lack access to solutions they can utilize routinely at home."

The LibAirty™ System marks a groundbreaking advancement in technology, merging controlled breathing with targeted chest compressions to provide superior airway clearance. In clinical studies conducted at esteemed institutions like the Medical University of South Carolina (MUSC) and Sheba Medical Center, LibAirty demonstrated to be twice as effective as traditional vest-based therapies. It also garnered significantly higher user satisfaction scores, validating its potential to transform patient outcomes.

Dr. Patrick Flume, a pulmonologist and director of the Adult Cystic Fibrosis Center at MUSC Health, expressed his enthusiasm for this new system, stating, "Our study demonstrated that LibAirty has the potential to enhance clinical outcomes for a significant group of patients. I am excited to have LibAirty as a solution for those who need effective airway clearance at home."

The genesis of the LibAirty™ System lies in the principles of Autogenic Drainage, a recognized technique for airway clearance that traditionally demands extensive patient training and the support of respiratory therapists. However, the innovative design of LibAirty simplifies this process. The accompanying patient app provides guidance on breathing techniques, while the wearable vest delivers synchronized chest compressions, efficiently directing airflow to clear even the most challenging small airways.

Anat Shani, the CEO of Synchrony Medical, stated, "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." To build on this success, Synchrony Medical will establish its U.S. headquarters in Jersey City, New Jersey, and plans for a limited rollout of the LibAirty™ system in select locations later in 2025.

As the company gears up for its product launch, Synchrony Medical aims to forge partnerships and scale production to make the LibAirty™ Airway Clearance System accessible to patients across the United States.

In conclusion, the FDA clearance of the LibAirty™ Airway Clearance System represents a significant advancement in at-home respiratory care, poised to provide patients with chronic lung diseases much-needed relief and improved quality of life. Synchrony Medical's commitment to accessibility and innovation sets the stage for a future where advanced respiratory care is within reach for all patients who need it most.