The U.S. FDA has released the special controls needed for extracorporeal carbon dioxide removal thanks to the successful pursuit of a de novo petition by Pittsburgh-based Alung Technologies Inc., but generating the clinical data for successor 510(k) devices will be no mean feat. While some of the associated in vivo testing may be performed on animal models, the list is extensive and includes testing for hemodynamic instability and inadequate gas exchange, all reasons that Alung and the FDA needed the better part of a decade to bring this device to the U.S. market.
Patients and investors in Alung Technologies Inc. can breathe a little easier now that the company’s Hemolung respiratory assist system has won a de novo approval from the FDA. The FDA approval comes more than eight years after Hemolung received CE mark and Health Canada approval. Hemolung gained FDA emergency use authorization for patients with COVID-19 in April 2020.
Pittsburgh-based Alung Technologies Inc. has received emergency use authorization from the U.S. FDA for its Hemolung Respiratory Assist System (RAS) to treat lung failure caused by COVID-19. The technology could help to ease demand for ventilators, which have been in short supply in coronavirus hot spots, and provide an alternative for patients who can’t tolerate mechanical ventilation.
