Jenscare Scientific Receives FDA Approval for Pivotal Trial of LuX-Valve Plus

Reuters

Feb 06

Jenscare Scientific Receives FDA Approval for Pivotal Trial of LuX-Valve Plus

Jenscare Scientific Co., Ltd. announced that its independently developed LuX-Valve Plus, a transcatheter tricuspid valve replacement system, has received unconditional Investigational Device Exemption $(IDE)$ approval from the U.S. Food and Drug Administration (FDA) for its pivotal clinical trial. This approval allows the company to proceed with the pivotal clinical trial of LuX-Valve Plus in the United States. The device has previously demonstrated positive performance in clinical trials conducted in China, Europe, and other regions. The company intends to advance patient enrollment for the pivotal trial and pursue future commercialization of the product in the U.S. and other global markets.

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. Jenscare Scientific Co. Ltd. published the original content used to generate this news brief via IIS, the Issuer Information Service operated by the Hong Kong Stock Exchange (HKex) (Ref. ID: HKEX-EPS-20260206-12018496), on February 06, 2026, and is solely responsible for the information contained therein.

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Ltd. published the original content used to generate this news brief via IIS, the Issuer Information Service operated by the Hong Kong Stock Exchange (HKex) (Ref. ID: HKEX-EPS-20260206-12018496), on February 06, 2026, and is solely responsible for the information contained therein.</span></i>\n</p>\n</div></body></html>\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"BK1100","symbol_name":"医疗保健设备","start_time":0,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20260206:nNDL2bTVcN:1","article_id":"2609559945","we_media_id":"1032215980","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2609559945","pubTimestamp":1770386109,"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":"Jenscare Scientific Co., Ltd. announced that its independently developed LuX-Valve Plus, a transcatheter tricuspid valve replacement system, has received unconditional Investigational Device Exemption  approval from the U.S. Food and Drug Administration  for its pivotal clinical trial. This approval allows the company to proceed with the pivotal clinical trial of LuX-Valve Plus in the United States. The device has previously demonstrated positive performance in clinical trials conducted in China, Europe, and other regions. The company intends to advance patient enrollment for the pivotal trial and pursue future commercialization of the product in the U.S. and other global markets.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. Jenscare","collect":0,"end_time":0,"defaultTopTitle":"","property":[],"viewcount":null,"language":"en","relate_stocks":{"BK1100":"医疗保健设备","09877":"健世科技-B"},"translate_title":"Jenscare Scientific获得FDA批准LuX-Valve Plus关键试验","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"09877":0.9},"content_text":"Jenscare Scientific Receives FDA Approval for Pivotal Trial of LuX-Valve Plus\n    \n\n        Jenscare Scientific Co., Ltd. announced that its independently developed LuX-Valve Plus, a transcatheter tricuspid valve replacement system, has received unconditional Investigational Device Exemption $(IDE)$ approval from the U.S. Food and Drug Administration (FDA) for its pivotal clinical trial. This approval allows the company to proceed with the pivotal clinical trial of LuX-Valve Plus in the United States. The device has previously demonstrated positive performance in clinical trials conducted in China, Europe, and other regions. The company intends to advance patient enrollment for the pivotal trial and pursue future commercialization of the product in the U.S. and other global markets.\n      \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. Jenscare Scientific Co. Ltd. published the original content used to generate this news brief via IIS, the Issuer Information Service operated by the Hong Kong Stock Exchange (HKex) (Ref. 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