Synchrony Medical received FDA 510(k) clearance for its LibAirty airway clearance system.
LibAirty addresses a need for patients with chronic lung diseases such as chronic obstructive pulmonary disease (COPD), bronchiectasis, and cystic fibrosis, the company said in a news release. It synchronizes controlled breathing with targeted chest compressions to deliver airway clearance.
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The company says clinical outcomes demonstrated the system was trice as effective compared to traditional vest-based therapy. Synchrony also reported higher user satisfaction scores.
Jersey City, New Jersey–based Synchrony developed the technology using autogenic drainage, a proven airway clearance technique. The company says it 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. It directs airflow to thoroughly clear even the hardest-to-reach small airways.
“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,” she adds.
