{"id":22976,"date":"2025-10-27T12:58:51","date_gmt":"2025-10-27T12:58:51","guid":{"rendered":"https:\/\/itbusinesstoday.com\/?p=22976"},"modified":"2025-10-27T12:58:51","modified_gmt":"2025-10-27T12:58:51","slug":"terumos-opuswave-and-dualview-catheter-earn-fda-nod","status":"publish","type":"post","link":"https:\/\/itbusinesstoday.com\/ja\/health-tech\/terumos-opuswave-and-dualview-catheter-earn-fda-nod\/","title":{"rendered":"\u30c6\u30eb\u30e2\u306eOPUSWAVE\u3068DualView\u30ab\u30c6\u30fc\u30c6\u30eb\u304cFDA\u306e\u627f\u8a8d\u3092\u53d6\u5f97"},"content":{"rendered":"<?xml encoding=\"utf-8\" ?><p><a href=\"https:\/\/www.terumois.com\/\" data-no-translation=\"\">Terumo Interventional Systems<\/a> (TIS), a part of Terumo Corporation, announced that the OPUSWAVE&reg; Dual Sensor Imaging System and DualView&reg; imaging catheter received U.S. FDA 510(k) clearance. The OPUSWAVE system combines Optical Frequency Domain Imaging (OFDI) with Intravascular Ultrasound (IVUS). This lets doctors image at the same time. They get a full view of coronary artery disease (CAD).<\/p><p>This is Terumo&rsquo;s first imaging launch in the U.S. They have a strong presence in Japan. There, imaging for PCI procedures ranks among the highest globally. The DualView catheter features a 150mm maximum pullback length, a 2.6 Fr. imaging profile, 6 Fr. guide compatibility, and a variable pullback speed up to 40mm\/second, enhanced with an advanced hydrophilic coating.<\/p><h4>\u3053\u3061\u3089\u3082\u304a\u8aad\u307f\u304f\u3060\u3055\u3044\uff1a <a class=\"p-url\" href=\"https:\/\/itbusinesstoday.com\/ja\/health-tech\/biotech\/offline-studio-partners-with-corundum-for-life-sciences-projects\/\" rel=\"bookmark\">\u30aa\u30d5\u30e9\u30a4\u30f3\u30fb\u30b9\u30bf\u30b8\u30aa\u3001\u30e9\u30a4\u30d5\u30b5\u30a4\u30a8\u30f3\u30b9\u30fb\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u3067\u30b3\u30e9\u30f3\u30c0\u30e0\u3068\u63d0\u643a<\/a><\/h4><p>The OPUSWAVE system&rsquo;s dual-modality imaging allows for superior lesion visualization, supporting more precise diagnosis and treatment planning for complex coronary cases.<\/p>","protected":false},"excerpt":{"rendered":"<p>Terumo Interventional Systems (TIS), a part of Terumo Corporation, announced that the OPUSWAVE&reg; Dual Sensor Imaging System and DualView&reg; imaging catheter received U.S. FDA 510(k) clearance. The OPUSWAVE system combines Optical Frequency Domain Imaging (OFDI) with Intravascular Ultrasound (IVUS). This lets doctors image at the same time. They get a full view of coronary artery disease (CAD).This is Terumo&rsquo;s first imaging launch in the U.S. They have a strong presence in Japan. There, imaging for PCI procedures ranks among the highest globally. The DualView catheter features a 150mm maximum pullback length, a 2.6 Fr. imaging profile, 6 Fr. guide compatibility, and a variable pullback speed up to 40mm\/second, enhanced with [&hellip;]<\/p>\n","protected":false},"author":7,"featured_media":23008,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_bbp_topic_count":0,"_bbp_reply_count":0,"_bbp_total_topic_count":0,"_bbp_total_reply_count":0,"_bbp_voice_count":0,"_bbp_anonymous_reply_count":0,"_bbp_topic_count_hidden":0,"_bbp_reply_count_hidden":0,"_bbp_forum_subforum_count":0,"wprm-recipe-roundup-name":"","wprm-recipe-roundup-description":"","postBodyCss":"","postBodyMargin":[],"postBodyPadding":[],"postBodyBackground":{"backgroundType":"classic","gradient":""},"footnotes":""},"categories":[208,89,211,237,1838,206],"tags":[8792,1363,8795,8793,8794],"ppma_author":[572],"class_list":["post-22976","post","type-post","status-publish","format-standard","has-post-thumbnail","category-apac","category-health-tech","category-japan","category-news","category-quick-reads","category-regional","tag-dualview-imaging-catheter","tag-health-tech","tag-hospital-operation","tag-opuswave","tag-terumo-interventional-systems"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.2 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Terumo Gets FDA Clearance for OPUSWAVE and DualView<\/title>\n<meta name=\"description\" content=\"Terumo Interventional Systems received FDA 510(k) clearance for its OPUSWAVE System and DualView Catheter, offering advanced dual imaging.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/itbusinesstoday.com\/ja\/health-tech\/terumos-opuswave-and-dualview-catheter-earn-fda-nod\/\" \/>\n<meta property=\"og:locale\" content=\"ja_JP\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Terumo Gets FDA Clearance for OPUSWAVE and DualView\" \/>\n<meta property=\"og:description\" content=\"Terumo Interventional Systems received FDA 510(k) clearance for its OPUSWAVE System and DualView Catheter, offering advanced dual imaging.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/itbusinesstoday.com\/ja\/health-tech\/terumos-opuswave-and-dualview-catheter-earn-fda-nod\/\" \/>\n<meta property=\"og:site_name\" content=\"itbusinesstoday\" \/>\n<meta property=\"article:published_time\" content=\"2025-10-27T12:58:51+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/itbusinesstoday.com\/wp-content\/uploads\/2025\/10\/Terumos-OPUSWAVE-and-DualView-Catheter-earn-FDA-Nod.webp\" \/>\n\t<meta property=\"og:image:width\" content=\"1201\" \/>\n\t<meta property=\"og:image:height\" content=\"800\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/webp\" \/>\n<meta name=\"author\" content=\"ITBT StaffWriter\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"\u57f7\u7b46\u8005\" \/>\n\t<meta name=\"twitter:data1\" content=\"ITBT StaffWriter\" \/>\n\t<meta name=\"twitter:label2\" content=\"\u63a8\u5b9a\u8aad\u307f\u53d6\u308a\u6642\u9593\" \/>\n\t<meta name=\"twitter:data2\" content=\"1\u5206\" \/>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"\u30c6\u30eb\u30e2\u304cOPUSWAVE\u3068DualView\u306eFDA\u8a8d\u53ef\u3092\u53d6\u5f97","description":"\u30c6\u30eb\u30e2 \u30a4\u30f3\u30bf\u30fc\u30d9\u30f3\u30b7\u30e7\u30ca\u30eb \u30b7\u30b9\u30c6\u30e0\u30ba\u793e\u306f\u3001\u9ad8\u5ea6\u306a\u30c7\u30e5\u30a2\u30eb\u30a4\u30e1\u30fc\u30b8\u30f3\u30b0\u3092\u63d0\u4f9b\u3059\u308bOPUSWAVE\u30b7\u30b9\u30c6\u30e0\u3068DualView\u30ab\u30c6\u30fc\u30c6\u30eb\u304cFDA 510(k)\u8a8d\u53ef\u3092\u53d6\u5f97\u3057\u307e\u3057\u305f\u3002.","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:\/\/itbusinesstoday.com\/ja\/health-tech\/terumos-opuswave-and-dualview-catheter-earn-fda-nod\/","og_locale":"ja_JP","og_type":"article","og_title":"Terumo Gets FDA Clearance for OPUSWAVE and DualView","og_description":"Terumo Interventional Systems received FDA 510(k) clearance for its OPUSWAVE System and DualView Catheter, offering advanced dual imaging.","og_url":"https:\/\/itbusinesstoday.com\/ja\/health-tech\/terumos-opuswave-and-dualview-catheter-earn-fda-nod\/","og_site_name":"itbusinesstoday","article_published_time":"2025-10-27T12:58:51+00:00","og_image":[{"width":1201,"height":800,"url":"https:\/\/itbusinesstoday.com\/wp-content\/uploads\/2025\/10\/Terumos-OPUSWAVE-and-DualView-Catheter-earn-FDA-Nod.webp","type":"image\/webp"}],"author":"ITBT StaffWriter","twitter_card":"summary_large_image","twitter_misc":{"\u57f7\u7b46\u8005":"ITBT StaffWriter","\u63a8\u5b9a\u8aad\u307f\u53d6\u308a\u6642\u9593":"1\u5206"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/itbusinesstoday.com\/health-tech\/terumos-opuswave-and-dualview-catheter-earn-fda-nod\/#article","isPartOf":{"@id":"https:\/\/itbusinesstoday.com\/health-tech\/terumos-opuswave-and-dualview-catheter-earn-fda-nod\/"},"author":{"name":"ITBT StaffWriter","@id":"https:\/\/itbusinesstoday-68b209.ingress-baronn.ewp.live\/#\/schema\/person\/94fb575e469aff25a4b938814d050f15"},"headline":"Terumo\u2019s OPUSWAVE and DualView Catheter earn FDA Nod","datePublished":"2025-10-27T12:58:51+00:00","mainEntityOfPage":{"@id":"https:\/\/itbusinesstoday.com\/health-tech\/terumos-opuswave-and-dualview-catheter-earn-fda-nod\/"},"wordCount":159,"publisher":{"@id":"https:\/\/itbusinesstoday-68b209.ingress-baronn.ewp.live\/#organization"},"image":{"@id":"https:\/\/itbusinesstoday.com\/health-tech\/terumos-opuswave-and-dualview-catheter-earn-fda-nod\/#primaryimage"},"thumbnailUrl":"https:\/\/itbusinesstoday.com\/wp-content\/uploads\/2025\/10\/Terumos-OPUSWAVE-and-DualView-Catheter-earn-FDA-Nod.webp","keywords":["DualView imaging catheter","Health tech","hospital operation","OPUSWAVE","Terumo Interventional Systems"],"articleSection":["APAC","Health Tech","Japan","News","Quick Reads","Regional"],"inLanguage":"ja"},{"@type":"WebPage","@id":"https:\/\/itbusinesstoday.com\/health-tech\/terumos-opuswave-and-dualview-catheter-earn-fda-nod\/","url":"https:\/\/itbusinesstoday.com\/health-tech\/terumos-opuswave-and-dualview-catheter-earn-fda-nod\/","name":"\u30c6\u30eb\u30e2\u304cOPUSWAVE\u3068DualView\u306eFDA\u8a8d\u53ef\u3092\u53d6\u5f97","isPartOf":{"@id":"https:\/\/itbusinesstoday-68b209.ingress-baronn.ewp.live\/#website"},"primaryImageOfPage":{"@id":"https:\/\/itbusinesstoday.com\/health-tech\/terumos-opuswave-and-dualview-catheter-earn-fda-nod\/#primaryimage"},"image":{"@id":"https:\/\/itbusinesstoday.com\/health-tech\/terumos-opuswave-and-dualview-catheter-earn-fda-nod\/#primaryimage"},"thumbnailUrl":"https:\/\/itbusinesstoday.com\/wp-content\/uploads\/2025\/10\/Terumos-OPUSWAVE-and-DualView-Catheter-earn-FDA-Nod.webp","datePublished":"2025-10-27T12:58:51+00:00","description":"\u30c6\u30eb\u30e2 \u30a4\u30f3\u30bf\u30fc\u30d9\u30f3\u30b7\u30e7\u30ca\u30eb \u30b7\u30b9\u30c6\u30e0\u30ba\u793e\u306f\u3001\u9ad8\u5ea6\u306a\u30c7\u30e5\u30a2\u30eb\u30a4\u30e1\u30fc\u30b8\u30f3\u30b0\u3092\u63d0\u4f9b\u3059\u308bOPUSWAVE\u30b7\u30b9\u30c6\u30e0\u3068DualView\u30ab\u30c6\u30fc\u30c6\u30eb\u304cFDA 510(k)\u8a8d\u53ef\u3092\u53d6\u5f97\u3057\u307e\u3057\u305f\u3002.","breadcrumb":{"@id":"https:\/\/itbusinesstoday.com\/health-tech\/terumos-opuswave-and-dualview-catheter-earn-fda-nod\/#breadcrumb"},"inLanguage":"ja","potentialAction":[{"@type":"ReadAction","target":["https:\/\/itbusinesstoday.com\/health-tech\/terumos-opuswave-and-dualview-catheter-earn-fda-nod\/"]}]},{"@type":"ImageObject","inLanguage":"ja","@id":"https:\/\/itbusinesstoday.com\/health-tech\/terumos-opuswave-and-dualview-catheter-earn-fda-nod\/#primaryimage","url":"https:\/\/itbusinesstoday.com\/wp-content\/uploads\/2025\/10\/Terumos-OPUSWAVE-and-DualView-Catheter-earn-FDA-Nod.webp","contentUrl":"https:\/\/itbusinesstoday.com\/wp-content\/uploads\/2025\/10\/Terumos-OPUSWAVE-and-DualView-Catheter-earn-FDA-Nod.webp","width":1201,"height":800,"caption":"Terumo"},{"@type":"BreadcrumbList","@id":"https:\/\/itbusinesstoday.com\/health-tech\/terumos-opuswave-and-dualview-catheter-earn-fda-nod\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/itbusinesstoday.com\/"},{"@type":"ListItem","position":2,"name":"Terumo\u2019s OPUSWAVE and DualView Catheter earn FDA Nod"}]},{"@type":"WebSite","@id":"https:\/\/itbusinesstoday-68b209.ingress-baronn.ewp.live\/#website","url":"https:\/\/itbusinesstoday-68b209.ingress-baronn.ewp.live\/","name":"\u30a4\u30c3\u30c8\u30d3\u30b8\u30cd\u30b9\u30c8\u30a5\u30c7\u30a4","description":"","publisher":{"@id":"https:\/\/itbusinesstoday-68b209.ingress-baronn.ewp.live\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/itbusinesstoday-68b209.ingress-baronn.ewp.live\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"ja"},{"@type":"Organization","@id":"https:\/\/itbusinesstoday-68b209.ingress-baronn.ewp.live\/#organization","name":"\u30a4\u30c3\u30c8\u30d3\u30b8\u30cd\u30b9\u30c8\u30a5\u30c7\u30a4","url":"https:\/\/itbusinesstoday-68b209.ingress-baronn.ewp.live\/","logo":{"@type":"ImageObject","inLanguage":"ja","@id":"https:\/\/itbusinesstoday-68b209.ingress-baronn.ewp.live\/#\/schema\/logo\/image\/","url":"https:\/\/itbusinesstoday.com\/wp-content\/uploads\/2025\/01\/Asset-1.png","contentUrl":"https:\/\/itbusinesstoday.com\/wp-content\/uploads\/2025\/01\/Asset-1.png","width":663,"height":275,"caption":"itbusinesstoday"},"image":{"@id":"https:\/\/itbusinesstoday-68b209.ingress-baronn.ewp.live\/#\/schema\/logo\/image\/"}},{"@type":"Person","@id":"https:\/\/itbusinesstoday-68b209.ingress-baronn.ewp.live\/#\/schema\/person\/94fb575e469aff25a4b938814d050f15","name":"ITBT\u30b9\u30bf\u30c3\u30d5\u30e9\u30a4\u30bf\u30fc","image":{"@type":"ImageObject","inLanguage":"ja","@id":"https:\/\/itbusinesstoday.com\/wp-content\/uploads\/2025\/01\/Favicon-1.png90b3cb23d1d9c08733d969d29ea2d30d","url":"https:\/\/itbusinesstoday.com\/wp-content\/uploads\/2025\/01\/Favicon-1.png","contentUrl":"https:\/\/itbusinesstoday.com\/wp-content\/uploads\/2025\/01\/Favicon-1.png","caption":"ITBT StaffWriter"},"description":"ITBT\u30b9\u30bf\u30c3\u30d5\u30e9\u30a4\u30bf\u30fc\u306f\u3001IT Business Today\u306e\u793e\u5185\u5bc4\u7a3f\u8005\u3067\u3001\u30bf\u30a4\u30e0\u30ea\u30fc\u306a\u30cb\u30e5\u30fc\u30b9\u3068QuickBytes\u306e\u914d\u4fe1\u3092\u62c5\u5f53\u3057\u3066\u3044\u307e\u3059\u3002IT\u3001\u30cf\u30a4\u30c6\u30af\u3001\u4f01\u696d\u30bd\u30ea\u30e5\u30fc\u30b7\u30e7\u30f3\u306e\u6700\u65b0\u52d5\u5411\u3092\u30ab\u30d0\u30fc\u3057\u3001\u7c21\u6f54\u3067\u30a4\u30f3\u30d1\u30af\u30c8\u306e\u3042\u308b\u6700\u65b0\u60c5\u5831\u3092\u8aad\u8005\u306b\u63d0\u4f9b\u3057\u3066\u3044\u307e\u3059\u3002","sameAs":["https:\/\/itbusinesstoday.com\/"],"url":"https:\/\/itbusinesstoday.com\/ja\/author\/itbt-staffwriter\/"}]}},"authors":[{"term_id":572,"user_id":7,"is_guest":0,"slug":"itbt-staffwriter","display_name":"ITBT StaffWriter","avatar_url":{"url":"https:\/\/itbusinesstoday.com\/wp-content\/uploads\/2025\/01\/Favicon-1.png","url2x":"https:\/\/itbusinesstoday.com\/wp-content\/uploads\/2025\/01\/Favicon-1.png"},"author_category":"","first_name":"ITBT","last_name":"StaffWriter","user_url":"https:\/\/itbusinesstoday.com\/","job_title":"","description":"ITBT\u30b9\u30bf\u30c3\u30d5\u30e9\u30a4\u30bf\u30fc\u306f\u3001IT Business Today\u306e\u793e\u5185\u5bc4\u7a3f\u8005\u3067\u3001\u30bf\u30a4\u30e0\u30ea\u30fc\u306a\u30cb\u30e5\u30fc\u30b9\u3068QuickBytes\u306e\u914d\u4fe1\u3092\u62c5\u5f53\u3057\u3066\u3044\u307e\u3059\u3002IT\u3001\u30cf\u30a4\u30c6\u30af\u3001\u4f01\u696d\u30bd\u30ea\u30e5\u30fc\u30b7\u30e7\u30f3\u306e\u6700\u65b0\u52d5\u5411\u3092\u30ab\u30d0\u30fc\u3057\u3001\u7c21\u6f54\u3067\u30a4\u30f3\u30d1\u30af\u30c8\u306e\u3042\u308b\u6700\u65b0\u60c5\u5831\u3092\u8aad\u8005\u306b\u63d0\u4f9b\u3057\u3066\u3044\u307e\u3059\u3002"}],"_links":{"self":[{"href":"https:\/\/itbusinesstoday.com\/ja\/wp-json\/wp\/v2\/posts\/22976","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/itbusinesstoday.com\/ja\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/itbusinesstoday.com\/ja\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/itbusinesstoday.com\/ja\/wp-json\/wp\/v2\/users\/7"}],"replies":[{"embeddable":true,"href":"https:\/\/itbusinesstoday.com\/ja\/wp-json\/wp\/v2\/comments?post=22976"}],"version-history":[{"count":3,"href":"https:\/\/itbusinesstoday.com\/ja\/wp-json\/wp\/v2\/posts\/22976\/revisions"}],"predecessor-version":[{"id":23009,"href":"https:\/\/itbusinesstoday.com\/ja\/wp-json\/wp\/v2\/posts\/22976\/revisions\/23009"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/itbusinesstoday.com\/ja\/wp-json\/wp\/v2\/media\/23008"}],"wp:attachment":[{"href":"https:\/\/itbusinesstoday.com\/ja\/wp-json\/wp\/v2\/media?parent=22976"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/itbusinesstoday.com\/ja\/wp-json\/wp\/v2\/categories?post=22976"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/itbusinesstoday.com\/ja\/wp-json\/wp\/v2\/tags?post=22976"},{"taxonomy":"author","embeddable":true,"href":"https:\/\/itbusinesstoday.com\/ja\/wp-json\/wp\/v2\/ppma_author?post=22976"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}