The US Meals and Drug Administration (FDA) has granted 510(okay) clearance to Telesair Inc’s Bonhawa high-flow oxygen remedy system, designed to boost the remedy of sufferers with respiratory insufficiency.
In August, Bonhawa obtained CE Mark approval beneath the European Medical System Regulation (MDE).
Bonhawa, a light-weight oxygen remedy system, provides healthcare suppliers and their sufferers an prolonged circulation vary, a streamlined disinfection course of, and an intuitive touchscreen, providing larger capabilities and efficiencies, in line with a launch from the Southern California-based firm.
“The perfect-in-class Bonhawa system vastly improves affected person care whereas enhancing effectivity for clinicians,” says Bryan Liu, PhD, CEO of Telesair, in a launch. “It represents a major milestone in that it’s a cheaper, user-friendly choice for treating respiratory circumstances. Bonhawa is the one standalone high-flow oxygen remedy system designed by consultants in air flow. Our group has many years of expertise growing and commercializing revolutionary respiratory options and collaborated to create this environment friendly, easy-to-use system. I’m very pleased with the group for attaining each MDR/CE and FDA clearance in lower than one 12 months.”
Telesair is actively engaged in growing its first-in-class next-generation home-based platform and is assured in its capability to swiftly introduce its expertise to the market, in line with Liu.
Picture caption: Bonhawa high-flow oxygen remedy system
Picture credit score: Telesair Inc