{"id":8047,"date":"2024-10-02T11:20:36","date_gmt":"2024-10-02T09:20:36","guid":{"rendered":"https:\/\/www.positrigo.com\/?p=8047"},"modified":"2024-10-15T08:13:16","modified_gmt":"2024-10-15T06:13:16","slug":"positrigo-secures-ce-mark-in-europe-for-its-pioneering-dedicated-brain-pet-system","status":"publish","type":"post","link":"https:\/\/www.positrigo.com\/en-gb\/positrigo-secures-ce-mark-in-europe-for-its-pioneering-dedicated-brain-pet-system\/","title":{"rendered":"Positrigo Secures CE Mark in Europe for its Pioneering Dedicated Brain PET System"},"content":{"rendered":"\n\n\n\n\n\n<section id=\"res-header-image-block_619ca098a7574\" class=\"res-block res-header-image alignfull\">\n  <div class=\"res-header-img-outside mb-4\" data-aos=\"res-fadeIn\">\n\t<div class=\"res-header-height\">\n\t\t\n\t\n\t  <style> \n\t\t  @media only screen and (min-width: 970px) {\n\t\t\t #res-header-image-block_619ca098a7574.res-header-image .layout-1.header-img-height { height: 70vh;}  \n\t\t\t #res-header-image-block_619ca098a7574.res-header-image .layout-1 .res-header-image-vertical-center { top: 72%;} \n\t\t\t   \n\t\t  }\n\t\t  @media only screen and (max-width: 970px) {  \n\t\t\t#res-header-image-block_619ca098a7574.res-header-image .layout-1.header-img-height { height: 55vh;} \n\t\t\t#res-header-image-block_619ca098a7574.res-header-image .layout-1 .res-header-image-vertical-center { top: 55%;} \n\t\t\t    \n\t\t\t  \t\t  }\n\t\t   \n\t\t\t  @media only screen and (min-width: 1280px) {\n\t\t\t\t\t\t\t\t#res-header-image-block_619ca098a7574.res-header-image .layout-1 h1 {font-size: 200%; line-height: 105%;}\t\t\t\t \n\t\t\t\t\t\t\t\t\t\t\t  }   \n\t\t \t  <\/style> \n\t\t\n\t  <div class=\"layout-1 jarallax header-img-height\" data-speed=\"0.6\" style=\"background-color: #fff;\">\n\t\t  \n\t\t\t\t<div class=\"res-header-image-vertical-center\">\n\t\t\t\t\t<div class=\"container-fluid\">\n\t\t\t\t\t\t\n\t\t\t\t\t\t<div class=\"sloganBox\">\n                           <div class=\"row\">\n                             <div class=\"col col-md-10 text-left\">\n\t\t\t\t\t\t\t\t <div class=\" \" data-aos=\"res-fadeIn\">\n\t\t\t\t\t\t\t\t \n                                \t\n\t\t\t\t\t\t\t\t \n                                  \n\t\t\t\t\t\t\t\t \t<h2>NeuroLF now with CE Mark<\/h2>\n                                \t\t\t\t\t\t\t\t \n                                \t\n\t\t\t\t\t\t\t\t \n\t\t\t\t\t\t\t\t\t\n\n\t\t\t\t\t\t\t\t \t\t\t\t\t\t\t\t \t\n\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t                 <\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\n                                            <img decoding=\"async\" class=\"jarallax-img img-fluid\" src=\"https:\/\/www.positrigo.com\/wp-content\/uploads\/2024\/10\/CE-Mark-2-1920x1080.jpg\"  style=\"opacity: 0.8;\" alt=\"\"\/>\n                    \t\t  \n\t\t\t\t\n\t\t   <\/div>\n\t\t\t \n\t \n\n\n\t\t<\/div>\n\t<\/div>\n<\/section>\t\n\n\n\n<section id=\"res-txt-block_619ca0bca7575\" class=\"res-block res-txt layout01 p-no\" style=\"background: transparent;\">\n  <div class=\"inner-container container-off\" data-aos=\"res-fadeIn\">\n \n\t\t  \n\t\t \t  \n      \n      <div class=\"layout-1 txt-section\">\n\t\t<div class=\"row\">\t\n\t\t\t\n\t\t\n\t\t\t<div class=\"col-md-10 var-1spalten text-left\">\n\t\t\t\t\n\t\t\t\t<div class=\"txt-title-field\">\n\t\n\t\t\t\t\t\n\n\t\t\t\t  \n\t\t\t\t\t<h2>CE Mark and market clearance in Europe for NeuroLF<\/h2>\n\t\t\t\t\n\t\t\t\t\t\n\t\t\t\t\t \n\t\t\t\t\t<\/div> \n\t\t\t\t\t\n\t\t\t\t\t<div class=\"txt-textfield postContent pt-md-0\">\n\t\t\t\t\t\t\t\t\t\t  <p>October 2, 2024<\/p>\n<h4><\/h4>\n<h4><strong><b>European market clearance for the NeuroLF<sup>\u00ae<\/sup> System \u2013 a pioneering dedicated brain PET imaging system. This MDR approval (CE Mark) follows recent FDA clearance which makes NeuroLF the first device of its kind to obtain regulatory approval in the US and in Europe.<\/b><\/strong><\/h4>\n<p>&nbsp;<\/p>\n<p>Positrigo, a Swiss based company developing nuclear medical imaging devices to advance functional brain imaging, has achieved another major milestone with the CE Mark in Europe for its dedicated brain Positron Emission Tomography (PET) system <strong>NeuroLF<sup>\u00ae<\/sup><\/strong>. This innovative imaging device is ultra-compact and assists in diagnosing and monitoring of brain related disorders like Alzheimer\u2019s disease, Brain Tumors, Epilepsy, Parkinson\u2019s disease and others.<\/p>\n<p>\u201cThe CE mark of the NeuroLF system is another important milestone in the development of this dedicated brain PET system and represents a significant advance in the availability of brain PET imaging, allowing nuclear medicine physicians in Europe to offer a dedicated imaging modality to diagnose and monitor patients with brain related disorders\u201d, says <strong>Prof. Dr. med. Osama Sabri<\/strong>, Director and Chairman of the Department of Nuclear Medicine at the University of Leipzig Medical Center. Indeed, the NeuroLF system is much smaller and more affordable compared to the currently available clinical hybrid PET systems with a much larger footprint and weight and always combined with either MRI or CT. <strong>Dr. Jannis Fischer<\/strong>, co-founder and CEO of Positrigo states: \u201cAt Positrigo, we seek to push the limits by developing and commercializing new types of medical imaging technologies. The CE mark of the NeuroLF system is testament to this, now offering healthcare professionals the potential to improve the diagnosis for people living with brain related disorders like Alzheimer\u2019s disease (AD) while setting a new standard in brain PET imaging.\u201d<\/p>\n<p>&nbsp;<\/p>\n<h3><strong>Increased Demand for Brain PET in Europe<\/strong><\/h3>\n<p>The European Association of Nuclear Medicine (EANM) Neuroimaging Committee believes that amyloid PET is now at a historical turning point, where it has paved the way for early AD diagnosis. These experts expect that amyloid PET will be more widely used in the near future to justify the initiation and to monitor the effect of disease-modifying therapies on biological grounds (1). The Nuclear Medicine community should therefore be prepared to adjust its capacities to the increased demand for amyloid PET radiotracers, PET imaging infrastructure, and training for image reading and reporting in the near future. According to some estimates, the need for amyloid PET may increase by a factor of 20 (2). Thanks to the European market clearance of NeuroLF, Positrigo is now able to offer a solution which can improve the PET imaging infrastructure.<\/p>\n<p>&nbsp;<\/p>\n<h3><strong>Commercialization in Europe with selected partners<\/strong><\/h3>\n<p>Positrigo plans to sell its novel technology in Europe by leveraging a network of established companies in selected countries. \u201cDue to the fragmented healthcare system in Europe with different country specific purchase mechanisms and healthcare reimbursement systems, it is most efficient to partner with local companies in selected countries,\u201d explains <strong>Dr. Stefan Bircher<\/strong>, CCO at Positrigo. \u201cThis way we believe to achieve fast commercial traction and hope to be be able to offer best in class after sales support at the same time\u201d.<\/p>\n<p>The NeuroLF system is the first device of its kind which received market clearance in Europe and in the US. These two market approvals are important milestones for commercial opportunities in other parts of the world.<\/p>\n<p>&nbsp;<\/p>\n<p><strong>About Positrigo:<\/strong><\/p>\n<p>Positrigo is a pioneer in nuclear medical imaging technologies. Headquartered in Zurich, Switzerland, the medical device company was founded in 2018 as a spin-off of ETH Zurich. Positrigo\u2019s technology, development, clinical testing and commercialization has been supported by various private investors, the Swiss government and the European Innovation Council. NeuroLF \u2013 the company\u2019s first device \u2013 is an ultra-compact brain Positron Emission Tomography (PET) scanner which has applications in the assessment of causes of dementias, such as Alzheimer\u2019s disease and other brain related disorders.<\/p>\n<p>&nbsp;<\/p>\n<p><strong>References:<\/strong><\/p>\n<p><sup>1<\/sup><sup> \u00a0\u00a0<\/sup><a href=\"https:\/\/link.springer.com\/article\/10.1007\/s00259-023-06177-5\">FDA approval of lecanemab: the real start of widespread amyloid PET use? \u2014 the EANM Neuroimaging Committee perspective | European Journal of Nuclear Medicine and Molecular Imaging (springer.com)<\/a><\/p>\n<p><sup>2\u00a0 \u00a0<\/sup><a href=\"https:\/\/link.springer.com\/article\/10.1007\/s00259-021-05485-y\">The approval of a disease-modifying treatment for Alzheimer\u2019s disease: impact and consequences for the nuclear medicine community | European Journal of Nuclear Medicine and Molecular Imaging (springer.com)<\/a><\/p>\n\t\t\t\t\t\t\t\n\t\t\t\t\t<\/div> \n\t\t\t\t\t\n\t\t\t\t\t <div class=\"txt-textfield-btns pt-2 \">\n\t\t\t\t\t\t  \n\t\t\t\t\t<\/div> \n\t\t\t\t\n\t\t\t\t\t\t\n\t\n\t\t\t\t<\/div>\n\n\t\t \n\t\t\t\n\t\t\t\n\t\t\t\n\n\t\t\t\t\t\n\t\t <\/div> \t\n\t\t<\/div>\n\t \n\t  \n \n \n\t<\/div>\n<\/section>\n\n\n\n\n<p><\/p>\n\n\n\n<p><\/p>\n","protected":false},"excerpt":{"rendered":"<p>October 2, 2024 Positrigo secures CE Mark in Europe for NeuroLF System<\/p>\n","protected":false},"author":4,"featured_media":8138,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"content-type":"","footnotes":""},"categories":[18,1],"tags":[],"class_list":["post-8047","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news"],"_links":{"self":[{"href":"https:\/\/www.positrigo.com\/en-gb\/wp-json\/wp\/v2\/posts\/8047","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.positrigo.com\/en-gb\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.positrigo.com\/en-gb\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.positrigo.com\/en-gb\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/www.positrigo.com\/en-gb\/wp-json\/wp\/v2\/comments?post=8047"}],"version-history":[{"count":5,"href":"https:\/\/www.positrigo.com\/en-gb\/wp-json\/wp\/v2\/posts\/8047\/revisions"}],"predecessor-version":[{"id":8057,"href":"https:\/\/www.positrigo.com\/en-gb\/wp-json\/wp\/v2\/posts\/8047\/revisions\/8057"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.positrigo.com\/en-gb\/wp-json\/wp\/v2\/media\/8138"}],"wp:attachment":[{"href":"https:\/\/www.positrigo.com\/en-gb\/wp-json\/wp\/v2\/media?parent=8047"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.positrigo.com\/en-gb\/wp-json\/wp\/v2\/categories?post=8047"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.positrigo.com\/en-gb\/wp-json\/wp\/v2\/tags?post=8047"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}