{"id":1054,"date":"2019-08-07T14:44:00","date_gmt":"2019-08-07T14:44:00","guid":{"rendered":"https:\/\/quantadt.wpengine.com\/us\/?p=1054"},"modified":"2023-09-21T16:31:39","modified_gmt":"2023-09-21T16:31:39","slug":"quanta-begins-study-in-us-to-support-fda-submission","status":"publish","type":"post","link":"https:\/\/quantadt.com\/us\/quanta-begins-study-in-us-to-support-fda-submission\/","title":{"rendered":"Quanta Begins Study in US to support FDA Submission"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\"><strong>7 August 2019<\/strong>: Quanta Dialysis Technologies Ltd, a British medical technology company developing a personal haemodialysis system (SC+) for patient use in the clinic and the home, today announces that it has begun human factors testing of SC+ in the United States with Design Science, a leading specialist in medical device usability.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Human factors testing (HFT) is used to assess how intended users interact with a medical device in representative real\u2010world conditions. The HFT study will be conducted in the US with end users representing a diverse range of age and ethnicity of the adult US population, to evaluate the safety and effective use of Quanta\u2019s updated SC+ system. This represents an important step towards Quanta\u2019s 510(k) submission to the FDA planned for later this year and, ultimately, US market entry.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">From the beginning, SC+ has been designed with ease-of-use and patient safety as core attributes. Quanta has systematically applied state-of-the-art human factors engineering principles to develop a device that is simple and intuitive to operate, with the objective of empowering more patients to take control of their lives through self-care and home<br>haemodialysis.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">This study builds on earlier human factors testing conducted in the UK, as reported in Quanta\u2019s previously published <a href=\"https:\/\/onlinelibrary.wiley.com\/doi\/full\/10.1111\/hdi.12757\" target=\"_blank\" rel=\"noopener\">human factors paper<\/a> in Hemodialysis International.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>7 August 2019: Quanta Dialysis Technologies Ltd, a British medical technology company developing a personal haemodialysis system (SC+) for patient use in the clinic and the home, today announces that it has begun human factors testing of SC+ in the United States with Design Science, a leading specialist in medical device usability. Human factors testing [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":1055,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"content-type":"","footnotes":""},"categories":[7],"tags":[],"class_list":["post-1054","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-articles"],"acf":[],"_links":{"self":[{"href":"https:\/\/quantadt.com\/us\/wp-json\/wp\/v2\/posts\/1054","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/quantadt.com\/us\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/quantadt.com\/us\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/quantadt.com\/us\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/quantadt.com\/us\/wp-json\/wp\/v2\/comments?post=1054"}],"version-history":[{"count":0,"href":"https:\/\/quantadt.com\/us\/wp-json\/wp\/v2\/posts\/1054\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/quantadt.com\/us\/wp-json\/wp\/v2\/media\/1055"}],"wp:attachment":[{"href":"https:\/\/quantadt.com\/us\/wp-json\/wp\/v2\/media?parent=1054"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/quantadt.com\/us\/wp-json\/wp\/v2\/categories?post=1054"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/quantadt.com\/us\/wp-json\/wp\/v2\/tags?post=1054"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}