Somnetics plans to rapidly manufacture BiPAP machines to help healthcare providers address the demand for mechanical ventilation devices in the wake of Covid-19
Somnetics gets FDA EUA for non-invasive Ventilators to fight Covid-19. (Credit: Pixabay/Silas Camargo Silão)
Somnetics International has received the US Food and Drug Administration (FDA) Emergency Use Authorisation (EUA) for the supply of BiPAP machines and respiratory circuits to medical facilities to fight against Covid-19.
The Minnesota-based medical device company is supporting the local and regional medical facilities with an emergency supply of EUA BiPAP devices.
The devices have been purchased by the state of Minnesota and South Dakota medical facilities.
Somnetics CEO Clarence Johnson said: “We believe it’s our responsibility to do everything we can to support the medical community with the vital medical supplies they need during this time of crisis, and we are diverting production to this effort.
“It’s our honor, as well as our obligation, to provide this support to medical care providers fighting on the front line to manage this public health crisis.”
Somnetics designed new breathing circuit to control aerosolisation of virus particles
According to a prediction by experts, a shortage of critically needed mechanical ventilators is expected, while the healthcare system battles against the Covid-19.
Somnetics is expected to rapidly manufacture BiPAP machines to help healthcare providers address the demand for mechanical ventilation devices.
In addition, the company is repurposing its Transcend CPAP machines into EUA BiPAP machines to help patients who are facing difficulty in breathing due to the Covid-19 virus infection.
The company has also designed a new breathing circuit for the device to help control aerosolisation of virus particles to help protect healthcare workers.
The FDA has authorised the emergency use of continuous positive airway pressure machines (CPAPs) in healthcare settings to treat patients during the Covid-19 pandemic, in March 2020.
The US regulatory agency has not granted traditional approval for the Somnetics BiPAP machines, and authorisation allows the use of devices by medical facilities during the Covid-19 pandemic.