NEW YORK--(BUSINESS WIRE)--Nanotronics today announced that it has developed and designed nHale™, a bi-level positive air pressure (BIPAP) device to support spontaneously breathing adults weighing over 30 kg. The device has obtained Emergency Use Authorization (EUA) from the U.S. Food & Drug Administration (FDA) to assist patients suffering from COVID-19 disease in traditional healthcare facilities as well as spaces converted for the care of large numbers of COVID-19 patients. It is a noninvasive approach designed to be used in non-life-threatening situations, where a patient is in need of breathing assistance but is not in need of invasive ventilatory support based on standard medical protocols.
In response to Governor Cuomo’s Executive Emergency Order, Nanotronics used their status as an essential company, applying advanced AI, Intelligent Factory Control (IFC), and sophisticated engineering, to create nHale™. During development and testing, Nanotronics consulted with Northwell Hospital emergency medical physicians on the front lines of the most affected area of COVID-19, to ensure the product met the needs of practitioners.
“I was fortunate enough to use a BiPAP machine that provided me with respiratory support after having tested positive for COVID-19,” said Nanotronics CEO and cofounder, Matthew Putman. “Not everyone has that option simply because of accessibility, which to me is unacceptable, and why I feel great about bringing an affordable, human-centered BIPAP device to the people that need it most.”
Nanotronics applied deep in-house expertise to build a machine that is easily manufactured at scale, as well as at reduced cost, to increase accessibility for all Americans. The nHale™ device is designed for comfort and ease-of-use with the simplicity of one button. The machine is for use in hospitals and other healthcare facilities, such as emergency care spaces for COVID-19 patients, prison infirmaries, and nursing care facilities.
National Institute of Health (NIH) COVID-19 treatment guidelines state that noninvasive positive pressure ventilation, such as the nHale™ BIPAP device, is recommended where high-flow nasal cannula oxygen is not available and endotracheal intubation is not indicated.
In addition to distributing the nHale™ to hospitals, Nanotronics will donate a number of machines to healthcare facilities that traditionally serve communities of color and are disproportionally affected by COVID-19. As a partner in START-UP NY with City University of New York, Nanotronics will consult with educational leaders at Medgar Evers College as well as Shaka Senghor, Founder of Redeemed Sole, to determine where nHale™ is most needed within communities of color.
The nHale™ is a bi-level positive air pressure (BIPAP) device to support respiratory therapy of spontaneously breathing adults weighing over 30kg suffering from COVID-19 disease in traditional healthcare facilities. It is a non-invasive ventilator designed to be used in non-life-threatening situations, for spontaneously breathing patients, where a patient is in need of breathing assistance but is not in need of invasive ventilatory support based on standard medical protocols.
Nanotronics applied deep in-house expertise, incorporating advanced AI, Intelligent Factory Control (IFC), and sophisticated engineering to build a machine that is easily manufactured at scale and at a reduced cost to increase accessibility for all Americans. The nHale™ device is designed for comfort and ease-of-use with the simplicity of one button.
The machine is for use in hospitals and other healthcare facilities, such as converted emergency care spaces for COVID-19 patients, prison infirmaries, and nursing care facilities.
nHale™ has not been FDA cleared or approved;
nHale™ has been authorized by FDA under an EUA;
nHale™ is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of ventilators, ventilator tubing connectors, and ventilator accessories under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
nHale™ is a trademark of Nanotronics in the U.S. which can be found at www.nHaletherapy.com.
Nanotronics is a science technology company that has redefined factory control through the invention of a platform that combines AI, automation and sophisticated imaging to assist human ingenuity in detecting flaws and anomalies in manufacturing, an industry that has been stagnant since the 1950s. Deployed across eight countries and industry agnostic, Nanotronics works with leading-edge companies—from aerospace, to electronics, to healthcare—to drive up yield, reduce footprint and waste, lower costs, and speed up design iteration. For more information, visit www.nanotronics.co and follow @nanotronics.
Forward Looking Statement
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