{"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":"<p><a href=\"https:\/\/www.terumois.com\/\">\u30c6\u30eb\u30e2 \u30a4\u30f3\u30bf\u30fc\u30d9\u30f3\u30b7\u30e7\u30ca\u30eb \u30b7\u30b9\u30c6\u30e0\u30ba<\/a> (\u30c6\u30eb\u30e2\u682a\u5f0f\u4f1a\u793e\uff08\u672c\u793e\uff1a\u6771\u4eac\u90fd\u6e2f\u533a\u3001\u4ee3\u8868\u53d6\u7de0\u5f79\u793e\u9577 \u517c CEO\uff1a\u6771 \u54f2\u90ce\u3001\u4ee5\u4e0b\u30c6\u30eb\u30e2\uff09\u5098\u4e0b\u306eTIS\u682a\u5f0f\u4f1a\u793e\uff08\u672c\u793e\uff1a\u6771\u4eac\u90fd\u6e2f\u533a\u3001\u4ee3\u8868\u53d6\u7de0\u5f79\u793e\u9577\u517cCEO\uff1a\u8fbb\u6751 \u535a\u53f2\u3001\u4ee5\u4e0bTIS\uff09\u306f\u3001OPUSWAVE\u00ae Dual Sensor Imaging System\u304a\u3088\u3073DualView\u00ae\u30a4\u30e1\u30fc\u30b8\u30f3\u30b0\u30ab\u30c6\u30fc\u30c6\u30eb\u304c\u7c73\u56fdFDA 510(k)\u8a8d\u53ef\u3092\u53d6\u5f97\u3057\u305f\u3068\u767a\u8868\u3057\u307e\u3057\u305f\u3002OPUSWAVE\u30b7\u30b9\u30c6\u30e0\u306f\u3001\u5149\u5468\u6ce2\u6570\u9818\u57df\u30a4\u30e1\u30fc\u30b8\u30f3\u30b0\uff08OFDI\uff09\u3068\u8840\u7ba1\u5185\u8d85\u97f3\u6ce2\uff08IVUS\uff09\u3092\u7d44\u307f\u5408\u308f\u305b\u305f\u3082\u306e\u3067\u3059\u3002\u3053\u308c\u306b\u3088\u308a\u3001\u533b\u5e2b\u306f\u540c\u6642\u306b\u753b\u50cf\u3092\u5f97\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002\u3053\u308c\u306b\u3088\u308a\u3001\u533b\u5e2b\u306f\u51a0\u52d5\u8108\u75be\u60a3\uff08CAD\uff09\u306e\u5168\u5bb9\u3092\u628a\u63e1\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002<\/p>\n<p>\u30c6\u30eb\u30e2\u304c\u7c73\u56fd\u3067\u30a4\u30e1\u30fc\u30b8\u30f3\u30b0\u3092\u767a\u58f2\u3059\u308b\u306e\u306f\u3053\u308c\u304c\u521d\u3081\u3066\u3067\u3059\u3002DualView\u30ab\u30c6\u30fc\u30c6\u30eb\u306f\u3001\u6700\u5927\u5f15\u304d\u623b\u3057\u9577150mm\u30012.6Fr.\u306e\u30a4\u30e1\u30fc\u30b8\u30f3\u30b0\u30d7\u30ed\u30d5\u30a1\u30a4\u30eb\u30016Fr.\u306e\u30a4\u30e1\u30fc\u30b8\u30f3\u30b0\u30d7\u30ed\u30d5\u30a1\u30a4\u30eb\u3092\u5099\u3048\u3066\u3044\u307e\u3059\u3002DualView\u30ab\u30c6\u30fc\u30c6\u30eb\u306f\u3001\u6700\u5927\u5f15\u304d\u623b\u3057\u9577150mm\u30012.6Fr\u306e\u30a4\u30e1\u30fc\u30b8\u30f3\u30b0\u30d7\u30ed\u30d5\u30a1\u30a4\u30eb\u30016Fr\u306e\u30ac\u30a4\u30c9\u9069\u5408\u6027\u3001\u6700\u592740mm\/\u79d2\u306e\u53ef\u5909\u5f15\u304d\u623b\u3057\u901f\u5ea6\u304c\u7279\u5fb4\u3002<\/p>\n<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>\n<p>OPUSWAVE\u30b7\u30b9\u30c6\u30e0\u306e\u30c7\u30e5\u30a2\u30eb\u30e2\u30c0\u30ea\u30c6\u30a3\u30a4\u30e1\u30fc\u30b8\u30f3\u30b0\u306b\u3088\u308a\u3001\u75c5\u5909\u306e\u512a\u308c\u305f\u53ef\u8996\u5316\u304c\u53ef\u80fd\u3068\u306a\u308a\u3001\u8907\u96d1\u306a\u51a0\u52d5\u8108\u75c7\u4f8b\u306b\u5bfe\u3057\u3066\u3088\u308a\u6b63\u78ba\u306a\u8a3a\u65ad\u3068\u6cbb\u7642\u8a08\u753b\u3092\u30b5\u30dd\u30fc\u30c8\u3057\u307e\u3059\u3002<\/p>","protected":false},"excerpt":{"rendered":"<p>Terumo Interventional Systems (TIS), a part of Terumo Corporation, announced that the OPUSWAVE\u00ae Dual Sensor Imaging System and DualView\u00ae 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&#8217;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 [&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":{"0":"post-22976","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-apac","8":"category-health-tech","9":"category-japan","10":"category-news","11":"category-quick-reads","12":"category-regional","13":"tag-dualview-imaging-catheter","14":"tag-health-tech","15":"tag-hospital-operation","16":"tag-opuswave","17":"tag-terumo-interventional-systems"},"yoast_head":"<!-- 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