Medical technology company Inogen Inc (Nasdaq: INGN) announced on Monday that it has received FDA 510(k) clearance for the SIMEOX 200 Airway Clearance Device, enabling its introduction to the US market.

This next-generation device builds on the original Simeox, currently available internationally, to enhance bronchial drainage for patients with chronic respiratory diseases like Bronchiectasis, COPD, Cystic Fibrosis and Primary Ciliary Dyskinesia.

SIMEOX 200 uses high-frequency oscillatory vibrations and intermittent negative pressure during exhalation to mobilize bronchial secretions effectively, offering an innovative alternative to traditional airway clearance therapies. Designed for use in healthcare settings or at home, it is aimed at patients capable of independently generating a cough.

Inogen plans a limited US launch of the device in 2025, targeting specific sites. As a global leader in respiratory technology, Inogen continues to expand its portfolio of innovative homecare solutions, supporting patients and healthcare providers with advanced respiratory therapies.