GOLETA, California—Inogen Inc., a medical technology company offering respiratory products for the homecare industry, announced it has received 510(k) clearance by the U.S. Food and Drug Administration (FDA) for its ‘SIMEOX 200’ airway clearance device. The company said this FDA clearance aims to expand its market and help meet the needs of patients with chronic respiratory diseases.
“We are very excited to receive FDA clearance for the innovative SIMEOX 200 therapy for patients in the U.S.,” said Kevin Smith, president and CEO of Inogen. “By tapping into our well-established network of health care providers, (business-to-business) 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.”
The company’s SIMEOX 200 device aims 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 patients capable of independently generating cough. Additionally, the device seeks to help patients with chronic lung diseases associated with mucus hypersecretion and mucus retention, such as bronchiectasis, chronic obstructive pulmonary diseases, cystic fibrosis or primary ciliary dyskinesia.
The SIMEOX 200 device aims to provide efficient bronchial drainage to users, specifically in low lung volumes, that can be administered in health care centers and institutions, as well as at home. This year, the company said it plans to pursue a limited launch of SIMEOX 200 in targeted sites.