Southern California-based Telesair Inc, a developer of next-generation respiratory technology, received CE Mark approval under the European Medical Device Regulation for its Bonhawa high-flow oxygen therapy system for use in the treatment of patients with respiratory insufficiency.

The Bonhawa system is one of the first respiratory therapeutic devices from a US-based company to receive CE Mark under the new European Medical Device Regulation, according to a release from Telesair.

“Having our Bonhawa system approved for Europe is a major step in the evolution of Telesair as a company and opens the many markets which accept CE Mark,” says Bryan Liu, CEO of Telesair, in a release. “We were able to accomplish this goal in record time—less than 10 months—thanks to our combination of a great team of experienced professionals, genuinely innovative respiratory technology products, attention to detail, high-level process control, and exceptional value.”

The light and compact device features an extended flow range up to 80 L/pm, a simple disinfection process, and an easy-to-use touchscreen, allowing greater therapeutic range, efficient disinfection, the potential to reduce the workload of caregivers, and the ability to visualize patient settings and data from outside the room.

“We are already working on positioning our next-generation, home-based platform, which we also intend to get approved swiftly,” says Liu in the release.

Telesair’s CE Mark and introduction of its lightweight oxygen therapy system to Europe further expands the company’s existing market access that includes Latin America and Southeast Asia.

Photo caption: Bonhawa high-flow oxygen therapy system

Photo credit: Telesair Inc