December 30, 2024
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Inogen’s newest respiratory device gains FDA clearance

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Goleta-based Inogen, a medical technology specializing in the manufacturing of portable oxygen containers, announced Dec. 30 that it had received U.S. Food and Drug Administration clearance for the Simeox 200 Airway Clearance Device.

The clearance helps expand the company’s ability to market and meet the various needs of patients with chronic respiratory diseases in the U.S., according to a press release.

Inogen’s Simeox 200, the next-generation product of the same name, it intended to improve bronchial drainage by enhancing mobilization of bronchial secretions via high-frequency oscillatory vibrations and intermittent negative pressure to the airway during exhalation, according to a press release.

The device is intended to be prescribed for use in patients capable of independently generating cough, the company said in a press release.

“We are very excited to receive FDA clearance for the innovative SIMEOX 200 therapy for patients in the U.S.,” Inogen President and CEO Kevin Smith said in a press release.

“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.”

Inogen plans to pursue a limited launch of Simeox 200 in targeted sites in 2025, according to a press release.