Telesair announces that the U.S. FDA has cleared its Bonhawa High Flow Oxygen Therapy (HFOT) system, which is designed to enhance respiratory treatment. Bonhawa, a purpose-built high-flow system, has obtained both CE Mark/European Medical Device Regulation and FDA 510(k) clearance. It offers extended flow options and simplified disinfection, benefiting healthcare providers and institutions.
“It represents a significant milestone in that it is a more cost-effective, user-friendly option for treating respiratory conditions,” says Bryan Liu, PhD, CEO of Telesair. “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’s introduction of its lightweight oxygen therapy system to the US further expands the company’s existing market access that includes Europe, Latin America, Asia, and the Middle East.
Liu adds that Telesair is actively engaged in developing its next-generation home-based platform and is confident in its ability to swiftly introduce its revolutionary technology to the market.
Telesair is a Southern California-based technology company that develops solutions to help move patients from hospital to home sooner by providing compact, mobile respiratory care solutions to hospitals, long-term care and skilled nursing facilities, rural health providers, and in the homecare setting.