Telesair, Inc., a technology leader in the respiratory industry, announced today that it has received FDA clearance to market its Bonhawa High Flow Oxygen Therapy (HFOT) system, designed to enhance the treatment of patients with respiratory insufficiency. Bonhawa is now the only purpose-built high flow system to receive both the CE Mark/European Medical Device Regulation and FDA 510(k) clearance.
Bonhawa gives healthcare providers and their patients in the US and worldwide an extended flow range, a streamlined disinfection process and an intuitive touchscreen. These attributes collectively offer healthcare workers and institutions greater capabilities and efficiencies.
“The best in class Bonhawa system greatly improves patient care while enhancing efficiency for clinicians,” said Bryan Liu, PhD, CEO of Telesair. “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’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 added that 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 revolutionary technology to the market.