Airiver Medical Receives FDA Breakthrough Device Status for DCB

Airiver Medical receives FDA breakthrough device status for DCB

Airiver Medical has secured the US FDA breakthrough device designation for its pulmonary DCB intended for the treatment of central airway stenosis.The post Airiver Medical receives FDA breakthrough device status for DCB appeared first on Medical Device Network.

Airiver Medical wins FDA breakthrough nod for drug-coated balloon

Airiver Medical announced today that it received FDA breakthrough device designation for its pulmonary drug-coated balloon (DCB). Additionally, Airiver announced the first treated patients in a clinical trial for the DCB. The Brooklyn Park, Minnesota-based company designed its DCB to treat central airway stenosis. Central airway stenosis (airway narrowing) can lead to prolonged intubation, tracheostomy, stenting, tuberculosis or lung transplant.…