Spiro Wave emergency ventilator gains FDA authorization to address COVID-19 demand

A new project designed to help address the growing need for ventilator hardware in order to treat the most serious cases of COVID-19 achieved an important milestone today, getting FDA Emergency Use Authorization (EUA) for its units to be used and scaled for production. The hardware, dubbed “Spiro Wave,” is an emergency automated resuscitator that can be produced for less than $5,000, and that a team of engineers, doctors and researchers has already begun producing and delivering to care facilities.

The Spiro Wave essentially replicates the functionality of a manual resuscitator, a portable device that is typically operated manually to provide ventilation to emergency patients in case of emergency, but it automated the process, while still working with the same types of bags that are typically used with the manual version for easier sourcing of supplies.

Spiro Wave is based on MIT’s open-source E-Vent prototype design, which was created by researchers at the institution as one way to alleviate the shortage that resulted from the COVID-19 crisis. From that design, the team behind Spiro Wave, which includes the co-founders of Newlab, 10XBeta and Boyce Technologies, were able to go from design to production of their emergency ventilator in just a few weeks.

Manufacturing partner Boyce says that it can hopefully ramp production to as many as 500 per day, at its Long Island City production facility in Queens, and the first few hundred are already shipping out to facilities in NYC starting this week. The team is also now looking for international production scaling assistance with partners that are registered to produce medical devices with the FDA in order to increase supply even further.

The team behind this notes that it’s not meant to replace a full-fledged ventilator, but that it will instead help alleviate the drain on those resources used in emergency care situations where a respirator would be just as effective, but where the manual version is impractical in terms of staffing and prolonged use. Like so many other measures granted EUA, this may not be an ideal replacement for fully FDA-approved equipment and therapies, but it’s an innovative, scalable solution that could mean big differences in the level of care at overburdened healthcare facilities.