Quanterix Corporation's HD-X Simoa Immunoassay Analyzer Receives Class 1 Medical Device Approval in South Korea

Reuters

昨天

Quanterix Corporation's HD-X Simoa Immunoassay Analyzer Receives Class 1 Medical Device Approval in South Korea

Quanterix Corporation has announced that its HD-X Simoa Immunoassay Analyzer has received Class 1 Medical Device registration from the Ministry of Food and Drug Safety (MFDS) in South Korea, facilitated through its regional distribution partner, HS Biosystems. This regulatory approval marks a significant milestone for Quanterix, expanding its reach in the South Korean market. The HD-X Simoa platform is recognized for its ultrasensitive biomarker detection, playing a crucial role in advancing Alzheimer's disease diagnostics and research. This approval further solidifies Quanterix's position in the neurodegenerative space, supporting both clinical trials and diagnostic testing.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Quanterix Corporation published the original content used to generate this news brief via Business Wire (Ref. ID: 20250623801054) on June 23, 2025, and is solely responsible for the information contained therein.

免責聲明：投資有風險，本文並非投資建議，以上內容不應被視為任何金融產品的購買或出售要約、建議或邀請，作者或其他用戶的任何相關討論、評論或帖子也不應被視為此類內容。本文僅供一般參考，不考慮您的個人投資目標、財務狀況或需求。TTM對信息的準確性和完整性不承擔任何責任或保證，投資者應自行研究並在投資前尋求專業建議。

熱議股票

1
2
3
4
5
6
7
8
9
10

{"basename":"/hant","ssrTDKData":{"titleTemplate":"%s - 老虎證券","title":"老虎证券全球投资理财平台| 一站式投资美股新股港股A股","description":"老虎证券助您一站式投资美股，新股，港股，A股等全球金融理财产品。新加坡华人最信赖的在线投资平台，现在加入即享低费用，24/5 无时差炒美股投资理财！","keywords":"老虎證券,老虎證券開戶,老虎券商,老虎證券官網,老虎證券app,tigertrade老虎證券,股票,炒股,新加坡股票交易平臺,投資,投資理財","social":{"ogDescription":"老虎证券助您一站式投资美股，新股，港股，A股等全球金融理财产品。新加坡华人最信赖的在线投资平台，现在加入即享低费用，24/5 无时差炒美股投资理财！","ogImage":"https://c1.itigergrowtha.com/portal5/static/media/og-logo.be62fbe1.png","ogUrl":"https://www.itiger.com/hant/news/2545164724"},"companyName":"老虎證券"},"pageData":{"isMobile":false,"isTiger":false,"isTTM":true,"region":"SGP","license":"TBSG","edition":"fundamental"},"__swrFallback__":{"@#url:\"https://stock-news.skytigris.cn/v3/news\",params:#id:\"2545164724\",edition:\"fundamental\",,,undefined,":{"share":"https://ttm.financial/m/news/2545164724?lang=zh_TW&edition=fundamental","thumbnail":"","is_english":true,"pubTime":"2025-06-23 19:30","share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","id":"2545164724","market":"fut","top_or_hot":-1,"title":"Quanterix Corporation's HD-X Simoa Immunoassay Analyzer Receives Class 1 Medical Device Approval in South Korea","media":"Reuters","content":"<html xmlns=\"http://www.w3.org/1999/xhtml\" xmlns:newsg2=\"http://iptc.org/std/nar/2006-10-01/\" xmlns:xhtml=\"http://www.w3.org/1999/xhtml\"><head><title>\n      Quanterix Corporation's HD-X Simoa Immunoassay Analyzer Receives Class 1 Medical Device Approval in South Korea\n    </title></head><body><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<p>\n        Quanterix Corporation has announced that its HD-X Simoa Immunoassay Analyzer has received Class 1 Medical Device registration from the Ministry of Food and Drug Safety (MFDS) in South Korea, facilitated through its regional distribution partner, HS Biosystems. This regulatory approval marks a significant milestone for Quanterix, expanding its reach in the South Korean market. The HD-X Simoa platform is recognized for its ultrasensitive biomarker detection, playing a crucial role in advancing Alzheimer's disease diagnostics and research. This approval further solidifies Quanterix's position in the neurodegenerative space, supporting both clinical trials and diagnostic testing.\n      </p>\n</div><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<em>Disclaimer: <span>This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Quanterix Corporation published the original content used to generate this news brief via Business Wire (Ref. ID: 20250623801054) on June 23, 2025, and is solely responsible for the information contained therein.</span></em>\n</div></body></html>","source":null,"html":"<!DOCTYPE html>\n<html>\n<head>\n<meta http-equiv=\"Content-Type\" content=\"text/html; charset=utf-8\" />\n<meta name=\"viewport\" content=\"width=device-width,initial-scale=1.0,minimum-scale=1.0,maximum-scale=1.0,user-scalable=no\"/>\n<meta name=\"format-detection\" content=\"telephone=no,email=no,address=no\" />\n<title>Quanterix Corporation's HD-X Simoa Immunoassay Analyzer Receives Class 1 Medical Device Approval in South Korea</title>\n<style type=\"text/css\">\na,abbr,acronym,address,applet,article,aside,audio,b,big,blockquote,body,canvas,caption,center,cite,code,dd,del,details,dfn,div,dl,dt,\nem,embed,fieldset,figcaption,figure,footer,form,h1,h2,h3,h4,h5,h6,header,hgroup,html,i,iframe,img,ins,kbd,label,legend,li,mark,menu,nav,\nobject,ol,output,p,pre,q,ruby,s,samp,section,small,span,strike,strong,sub,summary,sup,table,tbody,td,tfoot,th,thead,time,tr,tt,u,ul,var,video{ font:inherit;margin:0;padding:0;vertical-align:baseline;border:0 }\nbody{ font-size:16px; line-height:1.5; color:#999; background:transparent; }\n.wrapper{ overflow:hidden;word-break:break-all;padding:10px; }\nh1,h2{ font-weight:normal; line-height:1.35; margin-bottom:.6em; }\nh3,h4,h5,h6{ line-height:1.35; margin-bottom:1em; }\nh1{ font-size:24px; }\nh2{ font-size:20px; }\nh3{ font-size:18px; }\nh4{ font-size:16px; }\nh5{ font-size:14px; }\nh6{ font-size:12px; }\np,ul,ol,blockquote,dl,table{ margin:1.2em 0; }\nul,ol{ margin-left:2em; }\nul{ list-style:disc; }\nol{ list-style:decimal; }\nli,li p{ margin:10px 0;}\nimg{ max-width:100%;display:block;margin:0 auto 1em; }\nblockquote{ color:#B5B2B1; border-left:3px solid #aaa; padding:1em; }\nstrong,b{font-weight:bold;}\nem,i{font-style:italic;}\ntable{ width:100%;border-collapse:collapse;border-spacing:1px;margin:1em 0;font-size:.9em; }\nth,td{ padding:5px;text-align:left;border:1px solid #aaa; }\nth{ font-weight:bold;background:#5d5d5d; }\n.symbol-link{font-weight:bold;}\n/* header{ border-bottom:1px solid #494756; } */\n.title{ margin:0 0 8px;line-height:1.3;color:#ddd; }\n.meta {color:#5e5c6d;font-size:13px;margin:0 0 .5em; }\na{text-decoration:none; color:#2a4b87;}\n.meta .head { display: inline-block; overflow: hidden}\n.head .h-thumb { width: 30px; height: 30px; margin: 0; padding: 0; border-radius: 50%; float: left;}\n.head .h-content { margin: 0; padding: 0 0 0 9px; float: left;}\n.head .h-name {font-size: 13px; color: #eee; margin: 0;}\n.head .h-time {font-size: 12.5px; color: #7E829C; margin: 0;}\n.small {font-size: 12.5px; display: inline-block; transform: scale(0.9); -webkit-transform: scale(0.9); transform-origin: left; -webkit-transform-origin: left;}\n.smaller {font-size: 12.5px; display: inline-block; transform: scale(0.8); -webkit-transform: scale(0.8); transform-origin: left; -webkit-transform-origin: left;}\n.bt-text {font-size: 12px;margin: 1.5em 0 0 0}\n.bt-text p {margin: 0}\n</style>\n</head>\n<body>\n<div class=\"wrapper\">\n<header>\n<h2 class=\"title\">\nQuanterix Corporation's HD-X Simoa Immunoassay Analyzer Receives Class 1 Medical Device Approval in South Korea\n</h2>\n<h4 class=\"meta\">\n<a class=\"head\" href=\"https://laohu8.com/wemedia/1032215980\">\n\n<div class=\"h-thumb\" style=\"background-image:url(https://community-static.tradeup.com/news/4567337cbdf294b657b1fa87c5488b48);background-size:cover;\"></div>\n\n<div class=\"h-content\">\n<p class=\"h-name\">Reuters </p>\n<p class=\"h-time smaller\">2025-06-23 19:30</p>\n</div>\n</a>\n</h4>\n</header>\n<article>\n<html xmlns=\"http://www.w3.org/1999/xhtml\" xmlns:newsg2=\"http://iptc.org/std/nar/2006-10-01/\" xmlns:xhtml=\"http://www.w3.org/1999/xhtml\"><head><title>\n      Quanterix Corporation's HD-X Simoa Immunoassay Analyzer Receives Class 1 Medical Device Approval in South Korea\n    </title></head><body><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<p>\n        Quanterix Corporation has announced that its HD-X Simoa Immunoassay Analyzer has received Class 1 Medical Device registration from the Ministry of Food and Drug Safety (MFDS) in South Korea, facilitated through its regional distribution partner, HS Biosystems. This regulatory approval marks a significant milestone for Quanterix, expanding its reach in the South Korean market. The HD-X Simoa platform is recognized for its ultrasensitive biomarker detection, playing a crucial role in advancing Alzheimer's disease diagnostics and research. This approval further solidifies Quanterix's position in the neurodegenerative space, supporting both clinical trials and diagnostic testing.\n      </p>\n</div><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<em>Disclaimer: <span>This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Quanterix Corporation published the original content used to generate this news brief via Business Wire (Ref. ID: 20250623801054) on June 23, 2025, and is solely responsible for the information contained therein.</span></em>\n</div></body></html>\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"QTRX","symbol_name":"Quanterix Corp","start_time":0,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20250623:nNDL5cp1qX:1","article_id":"2545164724","we_media_id":"1032215980","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2545164724","pubTimestamp":1750678222,"columns":[],"sourceInfo":null,"weMediaInfo":{"media_name":"Reuters","introduction":"Reuters.com brings you the latest news from around the world, covering breaking news in markets, business, politics, entertainment and technology","home_visible":1,"id":"1032215980","head_image":"https://community-static.tradeup.com/news/4567337cbdf294b657b1fa87c5488b48"},"summary":"Quanterix Corporation has announced that its HD-X Simoa Immunoassay Analyzer has received Class 1 Medical Device registration from the Ministry of Food and Drug Safety  in South Korea, facilitated through its regional distribution partner, HS Biosystems. This regulatory approval marks a significant milestone for Quanterix, expanding its reach in the South Korean market. The HD-X Simoa platform is recognized for its ultrasensitive biomarker detection, playing a crucial role in advancing Alzheimer's disease diagnostics and research. This approval further solidifies Quanterix's position in the neurodegenerative space, supporting both clinical trials and diagnostic testing.Disclaimer: This news brief was created by Public Technologies  using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Quanterix Corporati","collect":0,"end_time":0,"defaultTopTitle":"","property":[],"viewcount":null,"language":"en","relate_stocks":{"QTRX":"Quanterix Corp","BK4121":"生命科学工具和服务"},"translate_title":"Quanterix Corporation的HD-X Simoa免疫分析仪在韩国获得1类医疗器械批准","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"QTRX":0.9},"content_text":"Quanterix Corporation's HD-X Simoa Immunoassay Analyzer Receives Class 1 Medical Device Approval in South Korea\n    \n\n        Quanterix Corporation has announced that its HD-X Simoa Immunoassay Analyzer has received Class 1 Medical Device registration from the Ministry of Food and Drug Safety (MFDS) in South Korea, facilitated through its regional distribution partner, HS Biosystems. This regulatory approval marks a significant milestone for Quanterix, expanding its reach in the South Korean market. The HD-X Simoa platform is recognized for its ultrasensitive biomarker detection, playing a crucial role in advancing Alzheimer's disease diagnostics and research. This approval further solidifies Quanterix's position in the neurodegenerative space, supporting both clinical trials and diagnostic testing.\n      \n\nDisclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Quanterix Corporation published the original content used to generate this news brief via Business Wire (Ref. ID: 20250623801054) on June 23, 2025, and is solely responsible for the information contained therein.","kind":"highlight","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"1","news_tag":"productRelease","news_rank":0,"symbols":[],"gpt_button":0,"code":"91000000","status":"200"}}}