FDA Unlikely to Approve LungFit PH System for PPHN by Year’s End

FDA Unlikely to Approve LungFit PH System for PPHN by Year’s End

313916

FDA Unlikely to Approve LungFit PH System for PPHN by Year’s End

Beyond Air has announced that it is not expecting the U.S. Food and Drug Administration (FDA) to approve its LungFit PH device to treat persistent pulmonary hypertension of the newborn (PPHN) before the end of the year. Beyond Air filed an application with the FDA in late 2020 requesting approval. However, “based upon our ongoing communications with the FDA, the Company no longer believes that the U.S. commercial launch of LungFit PH will take place prior…

You must be logged in to read/download the full post.