Inogen Gets FDA Clearance for Airway Clearance Device

Dow Jones
30 Dec 2024
 

By Dean Seal

 

Inogen said regulators have cleared its SIMEOX 200 Airway Clearance Device to be used by U.S. patients with chronic respiratory diseases.

The medical technology company said Monday that the Food and Drug Administration's 510(k) clearance paves the way for a limited launch of SIMEOX 200 in targeted sites next year.

The device promotes bronchial drainage and is intended for patients with chronic lung diseases associated with mucus hypersecretion and mucus retention, including chronic obstructive pulmonary diseases, or COPD, and cystic fibrosis.

Chief Executive Kevin Smith said the company intends to bring the device to patients within the next year.

Shares rose 3.6% to $8.89 in premarket trading.

 

Write to Dean Seal at dean.seal@wsj.com

 

(END) Dow Jones Newswires

December 30, 2024 08:49 ET (13:49 GMT)

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