US-based medical technology company Telesair has received the US Food and Drug Administration (FDA) approval for its Bonhawa High Flow Oxygen Therapy (HFOT) system.

The Bonhawa HFOT system is a light and compact device, designed to enhance the therapeutic range of patients with respiratory insufficiency.

It features an extended flow range of up to 80L/pm, a simple disinfection process and an easy-to-use touchscreen, facilitating an enhanced therapeutic range.

The Bonhawa system enables effective disinfection, reduces the workload of caregivers, and facilitates the visualisation of patient settings and data from outside the room.

It is the only purpose-built system to receive both the CE Mark under the European Medical Device Regulation and FDA 510(k) regulatory approvals, said Telesair.

Telesair CEO Bryan Liu said: “The best-in-class Bonhawa system greatly improves patient care while enhancing efficiency for clinicians. 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 commercialising revolutionary respiratory solutions and collaborated to create this efficient, easy-to-use system.”

Telesair said that its Bonhawa system provides healthcare providers and their patients with an extended flow range, a streamlined disinfection process and an intuitive touchscreen.

The attributes will collectively contribute to enhancing the healthcare workers and their institutions’ capabilities and efficiencies.

The US launch of its lightweight oxygen therapy system will further expand its existing market access beyond Europe, Latin America, Asia and the Middle East, said the company.

Earlier this year, Telesair secured $22m in a Series A round financing led by Pasaca Capital with participation from existing and new investors.