Oct 19, 2023 | FDA Approvals, ICU & Ventilation, Therapy Devices
The US Food and Drug Administration (FDA) has granted 510(k) clearance to Telesair Inc’s Bonhawa high-flow oxygen therapy system, designed to enhance the treatment of patients with respiratory insufficiency.
In August, Bonhawa received CE Mark approval under the European Medical Device Regulation (MDE).
Bonhawa, a lightweight oxygen therapy system, gives healthcare providers and their patients an extended flow range, a streamlined disinfection process, and an intuitive touchscreen, offering greater capabilities and efficiencies, according to a release from the Southern California-based company.
“The best-in-class Bonhawa system greatly improves patient care while enhancing efficiency for clinicians,” says Bryan Liu, PhD, CEO of Telesair, in a release. “It represents a significant milestone in that it is a more cost-effective, user-friendly option for treating respiratory conditions. Bonhawa is the only standalone high-flow oxygen therapy system designed by experts in ventilation. Our team has decades of experience developing and commercializing revolutionary respiratory solutions and collaborated to create this efficient, easy-to-use system. I am very proud of the organization for achieving both MDR/CE and FDA clearance in less than one year.”
Telesair is actively engaged in developing its first-in-class next-generation home-based platform and is confident in its ability to swiftly introduce its technology to the market, according to Liu.
Photo caption: Bonhawa high-flow oxygen therapy system
Photo credit: Telesair Inc
This article originally appeared on rtmagazine.com