In October 2019, the ESM-UBT device received FDA 510(K) approval. The ESM-UBT is in over 30 countries and has saved thousands of lives.
The Vayu-bCPAP has been implemented in three countries and used to treat over 200 babies as of May 2020.
On May 5th, 2020, the Vayu-bCPAP device received FDA Emergency Use Authorization has since been requested and/or to neonatologists and pediatricians at the Children’s Hospital of Philadelphia (for Haiti), the University of Indiana (for Nigeria and Kenya), Italy (Tuscany Region), Bangladesh, India, Laos, Vietnam, Tanzania, Lakes Region of Kenya (World Bank), South Africa, Australia, and to senior midwives in the Ontario Association of Midwives in Canada.