The US Food and Drug Administration (FDA) has granted 510(k) clearance for Inogen’s SIMEOX 200 Airway Clearance Device for individuals suffering from chronic respiratory conditions.
The SIMEOX 200 is a new version of the original Simeox device, which is already available in select international markets.
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Designed to “promote and improve” bronchial drainage, the device employs high-frequency oscillatory vibrations and intermittent negative pressure to mobilise bronchial secretions during exhalation.
It is intended for use by individuals who can independently generate cough.
Furthermore, it could be beneficial for those with chronic lung conditions such as cystic fibrosis, bronchiectasis, chronic obstructive pulmonary diseases (COPD), and primary ciliary dyskinesia.
Compared to standard airway clearance therapies, the device claims to offer an ‘efficient’ alternative for bronchial drainage, especially at low lung volumes.
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By GlobalDataThe company noted that the new device can be used in various healthcare as well as in the at home settings.
Inogen president and CEO Kevin Smith said: “We are very excited to receive FDA clearance for the innovative SIMEOX 200 therapy for patients in the US.
“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.”
With the approval, the company plans to initiate a limited launch of the device in the targeted regions next year.
In October this year, the company commenced the US market release of the ‘Inogen Rove 4 Portable Oxygen Concentrator’.
The Rove 4 incorporates the company’s patented pulse-dose Intelligent Delivery Technology, which is ‘highly’ sensitive to breath detection and claims to deliver oxygen within the first 250 milliseconds of inhalation.
The company signed a definitive agreement to acquire Physio-Assist in a deal valued at approximately $45m in July last year.
