Inogen, Inc., a medical technology company that develops innovative respiratory products for use in the homecare setting, announced today that the SIMEOX 200 Airway Clearance Device has received 510(k) clearance from the United States Food and Drug Administration (FDA), expanding the company’s ability to market and meet the diverse needs of patients with chronic respiratory diseases in the United States.
SIMEOX 200 is the successor to the original Simeox (which is now accessible in select international countries). It is designed to enhance and improve bronchial drainage by increasing bronchial secretion mobilization through high frequency oscillatory vibrations and intermittent negative airway pressure during exhale. The gadget is designed to be prescribed for people who can cough independently. SIMEOX 200 is primarily intended to aid patients with chronic lung disorders characterized by mucus hypersecretion and retention, such as Bronchiectasis, COPD (Chronic Obstructive Pulmonary disorders), 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.”
Source: Inogen
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