BOSTON - May 6, 2020 - (Newswire.com)
The United States Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) of a life-saving medical device in the fight against COVID-19.
The device, called the Vayu Bubble CPAP (Vayu-bCPAP), is an effective means to help save newborns and infants from preventable respiratory distress deaths. It is high-quality, easy to use, and is extremely affordable, with production costs less than 1% of comparable devices. Vayu-bCPAP is one of several disruptive healthcare solutions supported by the Vayu Global Health Foundation, a 501(c)(3) organization. Vayu-bCPAP has now been approved by the FDA, clearing the way for distribution of these devices across the United States and around the world during the time of this pandemic.
The Vayu Global Health Foundation is donating b-CPAP devices to hospitals, healthcare facilities, states, and municipalities to help provide care for newborns and infants suffering respiratory distress. Deployment of the Vayu-bCPAP device will not only care for newborns in respiratory distress but also free up ventilators for adult COVID-19 patients.
“FDA approval is a phenomenal development that lets us provide a crucial life-saving tool to medical professionals fighting COVID-19 today,” said Dr. Thomas F. Burke, Director of the Global Health Innovation Lab in the Department of Emergency Medicine at the Massachusetts General Hospital and founder of the Vayu Global Health Foundation. “There is an untapped and immediately available source of ventilators to combat the COVID-19 crisis: In the United States, approximately 80% of neonatal intensive care units use full-service ventilators to provide respiratory support for newborns. The Vayu-bCPAP device can free up those ventilators.”
The FDA has specifically granted emergency use authorization for the use of Vayu-bCPAP devices for three primary uses:
1. The direct support of newborns and infants suffering from respiratory distress due to COVID-19.
2. To free up ventilators from NICUs, Special Care Units, and Level 2 Nurseries to be used for older COVID-19 patients. In these instances, the ventilators currently used on infants in these three facility types can be replaced by Vayu-bCPAP, which allows for those ventilators to aid other COVID-19 patients.
3. Facilitate the distribution of Vayu-bCPAP devices to lower-level hospitals in the US, Canada, and worldwide to assist with new births occurring at home, as many more births are likely to occur in the home setting due to stay-at-home orders and other national COVID-19 responses.
As of May 5, the Vayu-bCPAP devices have been shipped to neonatologists and pediatricians at the Children’s Hospital of Philadelphia (for Haiti), the University of Indiana (for Nigeria), the Ontario Association of Midwives, Italy, Bangladesh, Laos, Vietnam, Tanzania, India, and Kenya. Cape Town, Johannesburg, and Australia have also submitted requests to Vayu for aid.
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Original Source: Life-Saving Device to Free Up Ventilators for COVID-19 Granted FDA Emergency Use Authorization
