{"id":386612,"date":"2020-11-23T08:03:31","date_gmt":"2020-11-23T13:03:31","guid":{"rendered":"http:\/\/www.marketnewsdesk.com\/?p=386612"},"modified":"2020-11-23T08:03:31","modified_gmt":"2020-11-23T13:03:31","slug":"baxter-announces-u-s-fda-510k-clearance-of-homechoice-claria-with-sharesource","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/baxter-announces-u-s-fda-510k-clearance-of-homechoice-claria-with-sharesource\/","title":{"rendered":"Baxter Announces U.S. FDA 510(k) Clearance of Homechoice Claria with Sharesource"},"content":{"rendered":"<p>        <!--.bwalignc { text-align: center; list-style-position: inside }\n.bwlistdisc { list-style-type: disc }body {font:normal small Arial,Helvetica,sans-serif;color:#000;background-color:#fff;padding:24px;margin:0;} a img {border:0;} h3 {font-size:medium;color:#000;margin:0 0 1em 0; text-align:center;}-->  <\/p>\n<p class=\"bwalignc\"><b>Baxter Announces U.S. FDA 510(k) Clearance of Homechoice Claria with Sharesource<\/b><\/p>\n<ul class=\"bwlistdisc\">\n<li>\nLatest offering from global leader in automated peritoneal dialysis (APD) technology\n<\/li>\n<li>\nCleared for adult and pediatric populations\n<\/li>\n<li>\nAvailable in 38 languages to support expanded ease of use for patients\n<\/li>\n<li>\nFeatures <b>Sharesource<\/b>, the only two-way remote patient management platform available in the U.S. for patients with kidney failure\n<\/li>\n<\/ul>\n<p>DEERFIELD, Ill.&#8211;(<a href=\"http:\/\/www.businesswire.com\">BUSINESS WIRE<\/a>)&#8211;<br \/>\nBaxter International Inc. (NYSE:BAX), a global innovator in renal care, today announced U.S. Food and Drug Administration (FDA) clearance of the <b>Homechoice Claria<\/b> automated peritoneal dialysis (APD) system with <b>Sharesource <\/b>connectivity platform. <b>Homechoice Claria<\/b> combines a simple user interface with the benefits of <b>Sharesource<\/b>, the only two-way remote patient management platform for patients on peritoneal dialysis in the U.S. <b>Homechoice Claria<\/b> is cleared for both adult and pediatric populations.<sup>1<\/sup> The clearance follows the recent finalization of the End-Stage Renal Disease (ESRD) Treatment Choices (ETC) payment model, which aims to significantly increase the number of new patients with kidney failure who receive home dialysis and\/or organ transplants.\n<\/p>\n<p>\n\u201cOur goal remains to expand accessibility to home-based therapy for U.S. patients with kidney failure,\u201d said Gavin Campbell, general manager of Baxter\u2019s U.S. Renal Care business. \u201c<b>Homechoice Claria<\/b> with <b>Sharesource<\/b> will support accelerated home dialysis growth by bringing the benefits of a two-way connected automated peritoneal dialysis system combined with a simple, intuitive device to more patients in the U.S.\u201d\n<\/p>\n<p><b>Enabling Enhanced Care with Remote Patient Management<\/b><\/p>\n<p>\nWith one in four APD patients globally benefitting from Baxter\u2019s two-way remote patient management technology,<b> Sharesource<\/b> offers patients and clinicians the ability to stay closely connected to proactively address key aspects of peritoneal dialysis (PD) therapy. Through the platform\u2019s accurate, daily treatment data and analytics, clinicians can manage patients remotely and make timely therapy decisions while keeping patients safely at home. Clinicians using <b>Homechoice Claria<\/b> with <b>Sharesource<\/b> also have greater visibility to patient adherence patterns, which may allow for early intervention and an increased focus on proactive care.<sup>2<\/sup> To date, more than 6 million home dialysis treatments completed in the U.S. have been enabled by <b>Sharesource<\/b>, with over 20 million PD treatments managed around the world.\n<\/p>\n<p><b>Homechoice Claria <\/b>offers enhanced features that facilitate added convenience for patients and clinical teams, as well as best-in-class educational companions to further simplify the PD experience. For patients, intuitive control buttons and an easy-to-read screen complement straightforward instructions in 38 languages. To extend patients\u2019 learning beyond the clinic, MyClaria \u2013 a web-based app included as part of the <b>Homechoice Claria<\/b> system \u2013 features step-by-step, voice activated and enabled instructions to guide patients through therapy. For clinicians, MySharesource \u2013 also a web-based app \u2013 is a resource featuring step-by-step guidance and quick demo videos on how to use the <b>Sharesource <\/b>platform.\n<\/p>\n<p>\n\u201cWhen starting their patients on PD, clinicians are looking for ways to help manage their changing needs over time,\u201d said Amy O\u2019Brien, PD clinical specialist at Baxter. \u201cThe combination of features, insights and resources available through <b>Homechoice Claria <\/b>with <b>Sharesource<\/b> creates an accurate, efficient tool for therapy management, resulting in peace of mind for patients and the healthcare providers who support them.\u201d\n<\/p>\n<p>\nAdding<b> Homechoice Claria<\/b> to its APD cycler portfolio enhances Baxter\u2019s efforts to bring the benefits of <b>Sharesource<\/b> remote patient management to as many clinics and patients as possible in the U.S. Baxter will continue offering its <b>Sharesource<\/b>-enabled APD cycler, <b>Amia, <\/b>which offers additional features to support patients, including a touchscreen user interface and built-in voice guidance. The introduction of <b>Homechoice<\/b><b>Claria <\/b>follows several Baxter initiatives across the continuum of care to improve options for patients with kidney failure, including:\n<\/p>\n<ul class=\"bwlistdisc\">\n<li>\nLaunching <b><a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.baxterglobal.com%2Fckdandmepatient&amp;esheet=52333915&amp;newsitemid=20201123005595&amp;lan=en-US&amp;anchor=CKD%26amp%3BMe&amp;index=1&amp;md5=6118b42ed5741ebf6949268f25d3740d\">CKD&amp;Me<\/a>,<\/b> an app providing customized disease and therapy education for the individual learning needs of patients with chronic kidney disease.\n<\/li>\n<li>\nDeveloping the <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.pdempowers.com%2Fhcp%2Facademy&amp;esheet=52333915&amp;newsitemid=20201123005595&amp;lan=en-US&amp;anchor=PD+Excellence+Academy&amp;index=2&amp;md5=b61b16ba86f04c442e305ea0a9bf9158\">PD Excellence Academy<\/a>, a first-of-its-kind curriculum providing education to PD nurses in one easily-accessible online resource.\n<\/li>\n<\/ul>\n<p><b>Homechoice Claria <\/b>with <b>Sharesource <\/b>will be available in the U.S. in the coming weeks. More information is available at <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fclaria.baxter.com%2F&amp;esheet=52333915&amp;newsitemid=20201123005595&amp;lan=en-US&amp;anchor=Claria.Baxter.com&amp;index=3&amp;md5=9a076081e5d8289a89ecd41a07969477\">Claria.Baxter.com<\/a>.\n<\/p>\n<p><b>About Baxter <\/b><\/p>\n<p>\nEvery day, millions of patients and caregivers rely on Baxter\u2019s leading portfolio of critical care, nutrition, renal, hospital and surgical products. For more than 85 years, we\u2019ve been operating at the critical intersection where innovations that save and sustain lives meet the healthcare providers that make it happen. With products, technologies and therapies available in more than 100 countries, Baxter\u2019s employees worldwide are now building upon the company\u2019s rich heritage of medical breakthroughs to advance the next generation of transformative healthcare innovations. To learn more, visit <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.baxter.com&amp;esheet=52333915&amp;newsitemid=20201123005595&amp;lan=en-US&amp;anchor=www.baxter.com&amp;index=4&amp;md5=cdfdf91a3969b7a529d16e21926e97fc\">www.baxter.com<\/a> and follow us on <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Ftwitter.com%2Fbaxter_intl%3Fref_src%3Dtwsrc%255Egoogle%257Ctwcamp%255Eserp%257Ctwgr%255Eauthor&amp;esheet=52333915&amp;newsitemid=20201123005595&amp;lan=en-US&amp;anchor=Twitter&amp;index=5&amp;md5=563a2fd8f6f4a576d793fd4c137a3821\">Twitter<\/a>, <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fbaxter-healthcare%2F&amp;esheet=52333915&amp;newsitemid=20201123005595&amp;lan=en-US&amp;anchor=LinkedIn&amp;index=6&amp;md5=202a18674e1cc4eeb9922bb9143f4391\">LinkedIn<\/a> and <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.facebook.com%2FBaxterInternationalInc%2F&amp;esheet=52333915&amp;newsitemid=20201123005595&amp;lan=en-US&amp;anchor=Facebook&amp;index=7&amp;md5=bb01321bafe4261aa3226ee7777279b4\">Facebook<\/a>.\n<\/p>\n<p><b>Rx Only. <\/b>For safe and proper use of this device, refer to the full Instructions for Use.\n<\/p>\n<p>\nThe <b>Homechoice Claria<\/b> APD system is intended for automatic control of dialysis solution exchanges in the treatment of pediatric and adult renal failure patients undergoing peritoneal dialysis in the home healthcare environment, including comparable use in professional healthcare facilities.\n<\/p>\n<p><i>This release includes forward-looking statements concerning <b>Homechoice Claria<\/b> and <b>Sharesource<\/b>, including anticipated availability and potential benefits associated with their use. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: satisfaction of regulatory and other requirements; actions of regulatory bodies and other governmental authorities; product quality, manufacturing or supply, or patient safety issues; changes in law and regulations; and other risks identified in Baxter&#8217;s most recent filing on Form 10-K and other SEC filings, all of which are available on Baxter&#8217;s website. Baxter does not undertake to update its forward-looking statements.<\/i><\/p>\n<p>\nBaxter, <b>Homechoice Claria, Amia, CKD&amp;Me<\/b> and <b>Sharesource<\/b> are registered trademarks of Baxter International Inc.\n<\/p>\n<p><sup>1<\/sup> Homechoice Claria product indications (please refer to the Instructions for Use for more information)\n<\/p>\n<p><sup>2<\/sup> Firanek C. et al, Discrepancy between prescribed and actual APD prescription delivery: Identification using cycler remote management technology. EDTA 5-18-2017. Poster #MP557\n<\/p>\n<p><img decoding=\"async\" alt=\"\" src=\"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&amp;sty=20201123005595r1&amp;sid=flmnd&amp;distro=nx&amp;lang=en\" style=\"width:0;height:0\" \/><span class=\"bwct31415\" \/><\/p>\n<p id=\"mmgallerylink\"><span id=\"mmgallerylink-phrase\">View source version on businesswire.com: <\/span><span id=\"mmgallerylink-link\"><a href=\"https:\/\/www.businesswire.com\/news\/home\/20201123005595\/en\/\" rel=\"nofollow\">https:\/\/www.businesswire.com\/news\/home\/20201123005595\/en\/<\/a><\/span><\/p>\n<p>\nMedia Contact<br \/>\n<br \/>Andrea Johnson, (224) 948-5353<br \/>\n<br \/><a rel=\"nofollow\" href=\"mailto:media@baxter.com\">media@baxter.com<\/a><\/p>\n<p>\nInvestor Contact<br \/>\n<br \/>Clare Trachtman, (224) 948-3020\n<\/p>\n<p><b>KEYWORDS:<\/b> Illinois United States North America<\/p>\n<p><b>INDUSTRY KEYWORDS:<\/b> Biotechnology Medical Supplies Surgery General Health Health FDA Diabetes Medical Devices<\/p>\n<p><b>MEDIA:<\/b><\/p>\n<table cellpadding=\"3\" cellspacing=\"3\">\n<tr>\n<td><font face=\"Arial\" size=\"2\"><b>Logo<\/b><\/font><\/td>\n<\/tr>\n<tr>\n<td><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20201123005595\/en\/154729\/3\/baxter_blue.jpg\" alt=\"Logo\" \/><\/td>\n<\/tr>\n<tr>\n<td><font face=\"Arial\" size=\"2\"><\/font><\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"<p>Baxter Announces U.S. FDA 510(k) Clearance of Homechoice Claria with Sharesource Latest offering from global leader in automated peritoneal dialysis (APD) technology Cleared for adult and pediatric populations Available in 38 languages to support expanded ease of use for patients Features Sharesource, the only two-way remote patient management platform available in the U.S. for patients with kidney failure DEERFIELD, Ill.&#8211;(BUSINESS WIRE)&#8211; Baxter International Inc. (NYSE:BAX), a global innovator in renal care, today announced U.S. Food and Drug Administration (FDA) clearance of the Homechoice Claria automated peritoneal dialysis (APD) system with Sharesource connectivity platform. Homechoice Claria combines a simple user interface with the benefits of Sharesource, the only two-way remote patient management platform for patients on peritoneal dialysis in the U.S. &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/baxter-announces-u-s-fda-510k-clearance-of-homechoice-claria-with-sharesource\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;Baxter Announces U.S. FDA 510(k) Clearance of Homechoice Claria with Sharesource&#8221;<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-386612","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Baxter Announces U.S. FDA 510(k) Clearance of Homechoice Claria with Sharesource - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/baxter-announces-u-s-fda-510k-clearance-of-homechoice-claria-with-sharesource\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Baxter Announces U.S. FDA 510(k) Clearance of Homechoice Claria with Sharesource - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"Baxter Announces U.S. FDA 510(k) Clearance of Homechoice Claria with Sharesource Latest offering from global leader in automated peritoneal dialysis (APD) technology Cleared for adult and pediatric populations Available in 38 languages to support expanded ease of use for patients Features Sharesource, the only two-way remote patient management platform available in the U.S. for patients with kidney failure DEERFIELD, Ill.&#8211;(BUSINESS WIRE)&#8211; Baxter International Inc. (NYSE:BAX), a global innovator in renal care, today announced U.S. Food and Drug Administration (FDA) clearance of the Homechoice Claria automated peritoneal dialysis (APD) system with Sharesource connectivity platform. Homechoice Claria combines a simple user interface with the benefits of Sharesource, the only two-way remote patient management platform for patients on peritoneal dialysis in the U.S. &hellip; Continue reading &quot;Baxter Announces U.S. FDA 510(k) Clearance of Homechoice Claria with Sharesource&quot;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/baxter-announces-u-s-fda-510k-clearance-of-homechoice-claria-with-sharesource\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2020-11-23T13:03:31+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&amp;sty=20201123005595r1&amp;sid=flmnd&amp;distro=nx&amp;lang=en\" \/>\n<meta name=\"author\" content=\"Newsdesk\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Newsdesk\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"5 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/baxter-announces-u-s-fda-510k-clearance-of-homechoice-claria-with-sharesource\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/baxter-announces-u-s-fda-510k-clearance-of-homechoice-claria-with-sharesource\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"Baxter Announces U.S. FDA 510(k) Clearance of Homechoice Claria with Sharesource\",\"datePublished\":\"2020-11-23T13:03:31+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/baxter-announces-u-s-fda-510k-clearance-of-homechoice-claria-with-sharesource\\\/\"},\"wordCount\":1043,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/baxter-announces-u-s-fda-510k-clearance-of-homechoice-claria-with-sharesource\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/cts.businesswire.com\\\/ct\\\/CT?id=bwnews&amp;sty=20201123005595r1&amp;sid=flmnd&amp;distro=nx&amp;lang=en\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/baxter-announces-u-s-fda-510k-clearance-of-homechoice-claria-with-sharesource\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/baxter-announces-u-s-fda-510k-clearance-of-homechoice-claria-with-sharesource\\\/\",\"name\":\"Baxter Announces U.S. FDA 510(k) Clearance of Homechoice Claria with Sharesource - 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Market Newsdesk","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.marketnewsdesk.com\/index.php\/baxter-announces-u-s-fda-510k-clearance-of-homechoice-claria-with-sharesource\/","og_locale":"en_US","og_type":"article","og_title":"Baxter Announces U.S. FDA 510(k) Clearance of Homechoice Claria with Sharesource - Market Newsdesk","og_description":"Baxter Announces U.S. FDA 510(k) Clearance of Homechoice Claria with Sharesource Latest offering from global leader in automated peritoneal dialysis (APD) technology Cleared for adult and pediatric populations Available in 38 languages to support expanded ease of use for patients Features Sharesource, the only two-way remote patient management platform available in the U.S. for patients with kidney failure DEERFIELD, Ill.&#8211;(BUSINESS WIRE)&#8211; Baxter International Inc. (NYSE:BAX), a global innovator in renal care, today announced U.S. Food and Drug Administration (FDA) clearance of the Homechoice Claria automated peritoneal dialysis (APD) system with Sharesource connectivity platform. Homechoice Claria combines a simple user interface with the benefits of Sharesource, the only two-way remote patient management platform for patients on peritoneal dialysis in the U.S. &hellip; Continue reading \"Baxter Announces U.S. FDA 510(k) Clearance of Homechoice Claria with Sharesource\"","og_url":"https:\/\/www.marketnewsdesk.com\/index.php\/baxter-announces-u-s-fda-510k-clearance-of-homechoice-claria-with-sharesource\/","og_site_name":"Market Newsdesk","article_published_time":"2020-11-23T13:03:31+00:00","og_image":[{"url":"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&amp;sty=20201123005595r1&amp;sid=flmnd&amp;distro=nx&amp;lang=en","type":"","width":"","height":""}],"author":"Newsdesk","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Newsdesk","Est. reading time":"5 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/baxter-announces-u-s-fda-510k-clearance-of-homechoice-claria-with-sharesource\/#article","isPartOf":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/baxter-announces-u-s-fda-510k-clearance-of-homechoice-claria-with-sharesource\/"},"author":{"name":"Newsdesk","@id":"https:\/\/www.marketnewsdesk.com\/#\/schema\/person\/482f27a394d4fda80ecb5499e519d979"},"headline":"Baxter Announces U.S. FDA 510(k) Clearance of Homechoice Claria with Sharesource","datePublished":"2020-11-23T13:03:31+00:00","mainEntityOfPage":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/baxter-announces-u-s-fda-510k-clearance-of-homechoice-claria-with-sharesource\/"},"wordCount":1043,"image":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/baxter-announces-u-s-fda-510k-clearance-of-homechoice-claria-with-sharesource\/#primaryimage"},"thumbnailUrl":"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&amp;sty=20201123005595r1&amp;sid=flmnd&amp;distro=nx&amp;lang=en","inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/baxter-announces-u-s-fda-510k-clearance-of-homechoice-claria-with-sharesource\/","url":"https:\/\/www.marketnewsdesk.com\/index.php\/baxter-announces-u-s-fda-510k-clearance-of-homechoice-claria-with-sharesource\/","name":"Baxter Announces U.S. FDA 510(k) Clearance of Homechoice Claria with Sharesource - 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