Noninvasive Ventilator Obtains EUA from the FDA for At-Home Use for the Treatment of COVID-19

Nanotronics Health, LLC, obtains EUA from the FDA for its non-invasive bi-level positive air pressure device, nHale™, for respiratory therapy in private homes when prescribed by a qualified medical professional

This authorization includes the optional use of supplemental oxygen with nHale™

NEW YORK–Nanotronics Health, LLC, a subsidiary of Nanotronics, announced today that it has obtained Emergency Use Authorization (EUA) from the U.S. Food & Drug Administration (FDA) for its non-invasive ventilator, nHale™, for at-home use. Nanotronics Health, LLC, also received authorization for the nHale™ to be used with supplemental oxygen under a doctor’s prescription.

“This approval provides flexibility for home care solutions and treatment, especially in the COVID-SARS-2 era,” said Dr. Mathew Foley, Vice Chairman of Northwell Health, New York’s largest healthcare provider serving NYC, Long Island, and Westchester.

As knowledge of the disease progresses, medical professionals and the public have become aware of how crucial non-invasive ventilation is for COVID-19 patient care in the hospital and beyond. To meet this need, Nanotronics Health, LLC, leveraged Nanotronics’ deep in-house expertise, incorporating advanced AI, Intelligent Factory Control (IFC) and sophisticated engineering to conceive, design and manufacture the noninvasive ventilator in under 90 days.

nHale™ is accessible to patients at a fraction of the cost of other noninvasive ventilators. With a one-button approach, the device is designed for quality, comfort, and ease of use.

“We wanted to provide hospitals and consumers with an affordable respiratory option to promote healing and aid the treatment of COVID-19,” said Julie Orlando, President of Nanotronics Health, LLC. “An innovative manufacturing vision was essential for building and scaling this critical device quickly—to get it in the hands of those who need it most.”

Nanotronics Health, LLC, developed and designed nHale™ to assist spontaneously breathing adults suffering from COVID-19 disease. It is intended for use in non-life-threatening situations, such as a patient in need of breathing assistance but not in need of invasive ventilatory support based on standard medical protocols.

Nanotronics Health, LLC is a subsidiary of and powered by Nanotronics. The company uses Intelligent Factory Control (IFC) to build and scale medical devices that are affordable, accessible and well-designed. Our first product, nHale™, a non-invasive ventilator, was conceived, built, and obtained Emergency Use Authorization by the FDA within 90 days to treat patients suffering from COVID-19. After obtaining Emergency Use Authorization, Nanotronics immediately began producing and shipping devices.