FDA Approves Beyond Air’s LungFit PH for Newborn Pulmonary Hypertension

The FDA granted approval to Beyond Air’s LungFit PH to treat term and near-term neonates with hypoxic respiratory failure, also known as persistent pulmonary hypertension.

LungFit PH works by generating nitric oxide gas from room air in conjunction with a ventilator to treat pulmonary hypertension.

The agency has approved the oxygenation device for infants born after at least 34 weeks gestation with certain types of respiratory failure.

LungFit PH is Beyond Air’s first approved nitric oxide generator targeting pulmonary disease.