The Bonhawa HFOT is one of the first respiratory therapeutic devices from a US based company to receive CE Mark under the new European Medical Device Regulation (EC/MDR), largely considered to be among the most difficult approvals in the world to achieve
Telesair’s CE Mark and introduction of its lightweight oxygen therapy system to Europe further expands the company’s existing market access. (Credit: Joshua Chehov on Unsplash)
Telesair, an innovator of next generation respiratory technology, announced today that it has received CE (Conformité Européenne) Marking under the European Medical Device Regulation for its Bonhawa High Flow Oxygen Therapy (HFOT) system for use in the treatment of patients with respiratory insufficiency.
The Bonhawa HFOT is one of the first respiratory therapeutic devices from a US based company to receive CE Mark under the new European Medical Device Regulation (EC/MDR), largely considered to be among the most difficult approvals in the world to achieve.
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.
“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,” said Bryan Liu, CEO of Telesair. “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.”
“We are already working on positioning our next generation home-based platform which we also intend to get approved swiftly,” added Liu.
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.
Source: Company Press Release