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HomeFDAEnexor Granted FDA Emergency Use Authorization for New Ventilator - X-VENT

Enexor Granted FDA Emergency Use Authorization for New Ventilator – X-VENT

June 17, 2020

Enexor reported today that the U.S. Food and Drug Administration has granted an Emergency Use Authorization for the immediate delivery and use of a new ventilator, the X-VENT.

Enexor will start delivering ventilators to hospitals within a few days.

Guided by the medical team of physicians and respiratory therapists, led by Dr. Bill Walsh of Vanderbilt University’s Monroe Carrol Jr Children’s Hospital, a pioneer in ventilation technology and one of the design team members of the original oscillating ventilator, the X-VENT was designed to deliver the critical modes of ventilation required for COVID patients.  “The X-VENT is a sophisticated, complex, state-of-the-art ventilator capable of providing multiple modes of mechanical ventilation. The engineers did an amazing job keeping it simple, easy to use, and inexpensive. It is exactly what the physicians of the world need to support their patients through acute respiratory failure.” states Dr. Bill Walsh.

The X-VENT is one of the very few FDA EUA approved ventilators that does not use a bag valve mask (BVM) resuscitator (often referred to colloquially by the proprietary name “Ambu-bag”).  The X-VENT utilizes a piston-driven air system controlled by a Schneider Electric industrial-grade programmable logic computer (PLC). The system is designed for many years of use, and is self-calibrating, so it can easily be stored.  The X-VENT is priced significantly below the cost of a traditional ventilator to encourage worldwide use to impact more lives.

Enexor has leveraged its extensive engineering design, manufacturing, and operational capabilities to quickly design, test and manufacture the unique ventilator.  “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.”, states Jestings.

Enexor has already begun manufacturing ventilators. With the FDA approval, Enexor will ramp up manufacturing to meet the critical needs in the U.S. and internationally.

Medical Device News Magazinehttps://infomeddnews.com
Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

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