The nHale is a bi-level positive air pressure (BIPAP) device that supports the respiratory therapy of spontaneously breathing Covid-19 patients
Nanotronics Health, a subsidiary of Nanotronics, has received the US Food & Drug Administration (FDA) Emergency Use Authorization (EUA) for its non-invasive ventilator nHale, allowing the at-home treatment of Covid-19 patients.
Also, the US regulatory agency has authorised the ventilator for use with supplemental oxygen, to support the treatment of spontaneously breathing Covid-19 patients, under a doctor’s prescription.
The current authorisation follows the FDA’s previous EUA for nHale to support the non-invasive respiratory needs for adult Covid-19 patients weighing more than 30kg, granted in June 2020.
Nanotronics Health president Julie Orlando said: “We wanted to provide hospitals and consumers with an affordable respiratory option to promote healing and aid the treatment of Covid-19.
“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.”
nHale was developed using advanced AI, IFC and engineering technologies
The nHale is a bi-level positive air pressure (BIPAP) device that supports the respiratory therapy of spontaneously breathing Covid-19 patients weighing more than 30kg.
The non-invasive ventilator has been designed for use in non-life-threatening situations, such as patients needing breathing assistance but not the invasive ventilatory support, based on standard medical protocols.
The company has leveraged advanced AI, Intelligent Factory Control (IFC) and advanced engineering technologies to conceive, design and manufacture the non-invasive ventilator in under 90 days.
The device can be used in conventional healthcare facilities including hospitals, assisted living facilities, nursing homes, along with public spaces converted into Covid-19 treatment centres, including convention centres, university dormitories, motels, etc., said the company.
Also, nHale can also be used in home settings, where it requires supplemental oxygen to provide the patient airflow with increased oxygen concentration, when a doctor prescribes the treatment and user gets training from a qualified medical professional.