FDA grants emergency use authorisation to Enexor ventilators

18 June 2020 (Last Updated June 18th, 2020 11:25)

Enexor Health Systems has received emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for the immediate delivery and use of its new ventilator X-VENT.

FDA grants emergency use authorisation to Enexor ventilators
Enexor’s low-cost ventilator is said to be ideal for Covid-19 use in hospitals throughout the world. Credit: Enexor Health Systems.

Enexor Health Systems has received emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for the immediate delivery and use of its new ventilator X-VENT.

The ventilator is designed to provide the critical modes of ventilation needed for Covid-19 patients.

The X-VENT is one of the very few FDA EUA-approved ventilators that does not use a bag valve mask (BVM) resuscitator, the company noted.

It uses a piston-driven air system controlled by a Schneider Electric industrial-grade programmable logic computer (PLC). The system is designed to last many years and is also self-calibrating.

The company said that it has priced X-VENT lower than the cost of a traditional ventilator to facilitate worldwide use.

The device was developed with guidance from a medical team, including physicians and respiratory therapists, led by Dr Bill Walsh of Vanderbilt University’s Monroe Carrol Jr Children’s Hospital.

Dr Bill Walsh is one of the design team members of the original oscillating ventilator.

Enexor founder and CEO Lee Jestings said: “Enexor was created to help solve major world problems.

“In responding to Covid and future pandemics, we stayed true to our mission by putting together an incredible team of medical professionals, engineers and manufacturing specialists with the ultimate mission of designing and manufacturing a durable, reliable, easy to maintain and affordable ventilator that can be deployed at any hospital in the world to help save lives. The team delivered with the X-VENT.”

The company has already begun manufacturing ventilator and intends to scale up production to meet the critical requirements in the US and internationally.

With FDA approval, Enexor expects to deliver ventilators to hospitals in the next few days.