Synchrony Medical Secures FDA Clearance for LibAirty Airway Clearance System

By

Disclaimer: Images on MEDWIRE.AI are AI-generated for illustrative purposes and are not affiliated with, endorsed by, or representative of any specific company, product, or technology.

Synchrony Medical announced FDA 510(k) clearance for its LibAirty airway clearance system, targeting patients with chronic lung diseases such as COPD, bronchiectasis, and cystic fibrosis.

LibAirty combines controlled breathing guidance with synchronized chest compressions via a wearable vest and patient app. The system adapts autogenic drainage, a complex airway clearance technique, making it more accessible without extensive respiratory therapist support.

Clinical data demonstrated LibAirty’s effectiveness at triple that of traditional vest-based therapies, alongside improved user satisfaction.

CEO Anat Shani highlighted the clearance as a pivotal step in transforming respiratory care. Synchrony plans a limited US rollout later in 2025 and is establishing its US headquarters in New Jersey.

Follow MEDWIRE.AI for respiratory device innovations and regulatory updates.