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Airiver Medical

Airiver Medical wins FDA IDE for pulmonary drug-coated balloon

August 27, 2025 By Sean Whooley

Airiver Medical Drug-Coated Balloon DCB (1) (1)

Airiver Medical announced today that it received FDA investigational device exemption (IDE) for its pulmonary drug-coated balloon (DCB). The Brooklyn Park, Minnesota-based company designed its DCB to treat central airway stenosis. This FDA IDE – the company's first — allows it to begin a pivotal clinical trial of the technology. Central airway … [Read more...] about Airiver Medical wins FDA IDE for pulmonary drug-coated balloon

Filed Under: Balloons, Catheters, Coatings, Regulatory, Technologies & Devices Tagged With: Airiver Medical, fda

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