Southern California based Telesair has received CE (Conformit\u00e9 Europ\u00e9enne) 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.<\/p>\n\n\n\n
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.<\/p>\n\n\n\n
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.<\/p>\n\n\n\n
\u201cHaving 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,\u201d said Bryan Liu, CEO of Telesair. \u201cWe were able to accomplish this goal in record time \u2013 less than 10 months \u2013 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.\u201d<\/p>\n\n\n\n
\u201cWe are already working on positioning our next generation home-based platform which we also intend to get approved swiftly,\u201d added Liu.<\/p>\n\n\n\n
Telesair\u2019s CE Mark and introduction of its lightweight oxygen therapy system to Europe further expands the company\u2019s existing market access that includes Latin America and Southeast Asia.<\/p>\n","protected":false},"excerpt":{"rendered":"
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)<\/p>\n","protected":false},"author":2,"featured_media":23749,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"colormag_page_layout":"default_layout","footnotes":""},"categories":[6,25],"tags":[704],"class_list":["post-23748","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-europe","category-products-technologies","tag-ce-mark"],"_links":{"self":[{"href":"https:\/\/g-medtech.com\/news\/wp-json\/wp\/v2\/posts\/23748","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/g-medtech.com\/news\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/g-medtech.com\/news\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/g-medtech.com\/news\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/g-medtech.com\/news\/wp-json\/wp\/v2\/comments?post=23748"}],"version-history":[{"count":1,"href":"https:\/\/g-medtech.com\/news\/wp-json\/wp\/v2\/posts\/23748\/revisions"}],"predecessor-version":[{"id":23750,"href":"https:\/\/g-medtech.com\/news\/wp-json\/wp\/v2\/posts\/23748\/revisions\/23750"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/g-medtech.com\/news\/wp-json\/wp\/v2\/media\/23749"}],"wp:attachment":[{"href":"https:\/\/g-medtech.com\/news\/wp-json\/wp\/v2\/media?parent=23748"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/g-medtech.com\/news\/wp-json\/wp\/v2\/categories?post=23748"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/g-medtech.com\/news\/wp-json\/wp\/v2\/tags?post=23748"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}