FDA OKs Inogen’s Simeox 200 Airway Clearance Device

Inogen, a company focused on respiratory products for use in homecare, has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for its Simeox 200 airway clearance device.

Simeox 200 is the next generation of Inogen’s original Simeox. It’s meant to promote and improve bronchial drainage by boosting mobilization of bronchial secretions via high frequency oscillatory vibrations and intermittent negative pressure to the airway during exhalation.

The device is intended for prescription to patients that are capable of independently generating cough. Simeox 200 seeks to assist patients with chronic lung diseases associated with mucus hypersecretion and mucus retention, such as bronchiectasis, COPD (chronic obstructive pulmonary diseases), cystic fibrosis or primary ciliary dyskinesia.

The device was developed as an alternative to traditional airway clearance therapies, which can be time consuming and constraining with mixed results, according to Inogen. The company said it offers efficient bronchial drainage, specifically in low lung volumes. It can be administered in healthcare centers and institutions, as well as at home.

Inogen plans to launch Simeox 200 on a limited basis in targeted sites this year.

“We are very excited to receive FDA clearance for the innovative SIMEOX 200 therapy for patients in the U.S.,” said Kevin Smith, Inogen’s president and CEO. “By tapping into our well-established network of healthcare providers, B2B partners, and our Direct-to-Patient team, we aim to bring this next-generation airway clearance device to patients within the next year and significantly expand our reach over time.”

In October, the company launched its Rove 4 portable oxygen concentrator in the U.S. It features an additional, fourth flow setting that delivers up to 840 ml/minute of medical grade oxygen.