Inogen receives FDA 510(k) clearance for SIMEOX 200 airway clearance device

Inogen, Inc., a medical technology company offering innovative respiratory products for use in the homecare setting, today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the SIMEOX 200 Airway Clearance Device, expanding the company’s ability to market and meet the various needs of patients with chronic respiratory diseases in the U.S.

SIMEOX 200 is the next-generation of the original Simeox (currently available in select international markets). It is intended to promote and improve bronchial drainage by enhancing mobilization of bronchial secretions via high frequency oscillatory vibrations and intermittent negative pressure to the airway during exhalation. The device is intended to be prescribed for use in patients capable of independently generating cough. SIMEOX 200 is predominantly aimed to help 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.

We are very excited to receive FDA clearance for the innovative SIMEOX 200 therapy for patients in the U.S.,”

Kevin Smith, President and Chief Executive Officer, Inogen

“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.”

Traditional airway clearance therapies can be time consuming and constraining with mixed results. SIMEOX 200 provides an innovative alternative, delivering efficient bronchial drainage, specifically in low lung volumes, that can be administered in healthcare centers and institutions, as well as at home.

Inogen plans to pursue a limited launch of SIMEOX 200 in targeted sites in 2025.