Inogen OK’d to supply airway clearance device
By HME News Staff
Updated 9:15 AM CST, Mon December 30, 2024
GOLETA, Calif. – Inogen has received 510(k) clearance from the U.S. Food and Drug Administration 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.
Inogen entered into a definitive agreement to acquire Physio-Assist SAS, a privately held company based in France that makes the technology-enabled Simeox for $32 million in 2023.
“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. “By tapping into our well-established network of health care 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.”
SIMEOX 200 is the next generation of the original Simeox (currently available in select international markets).
The device 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. It is predominantly aimed to help patients with chronic lung diseases associated with mucus hypersecretion and mucus retention, such as bronchiectasis, COPD, cystic fibrosis or primary ciliary dyskinesia.
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