TransMedics Group Inc. Receives FDA Approval to Launch Next-Generation OCS Heart Trial

Reuters

08/04

<a href="https://laohu8.com/S/TMDX">TransMedics Group Inc.</a> Receives FDA Approval to Launch Next-Generation OCS Heart Trial

TransMedics Group Inc., a medical technology company specializing in organ transplant therapy, announced that it has received conditional approval from the U.S. Food and Drug Administration (FDA) for its Investigational Device Exemption $(IDE)$. This approval allows TransMedics to initiate its Next-Generation OCS ENHANCE Heart trial. The trial is a two-part clinical study aimed at demonstrating the benefits of prolonged heart perfusion using the OCS™ Heart System and comparing its effectiveness in donation after brain death $(DBD)$ cases to traditional static cold storage methods. With a sample size expected to exceed 650 patients, this trial is set to be the largest heart preservation for transplant trial ever conducted worldwide. This milestone marks a significant step in TransMedics' efforts to transform the standard of care in cardiothoracic transplants.

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. Transmedics Group Inc. published the original content used to generate this news brief via PR Newswire (Ref. ID: NE43286) on August 04, 2025, and is solely responsible for the information contained therein.

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Receives FDA Approval to Launch Next-Generation OCS Heart Trial","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      <a href=\"https://laohu8.com/S/TMDX\">TransMedics Group Inc.</a> Receives FDA Approval to Launch Next-Generation OCS Heart Trial\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        TransMedics Group Inc., a medical technology company specializing in organ transplant therapy, announced that it has received conditional approval from the U.S. Food and Drug Administration (FDA) for its Investigational Device Exemption <a href=\"https://laohu8.com/S/IDE\">$(IDE)$</a>. This approval allows TransMedics to initiate its Next-Generation OCS ENHANCE Heart trial. 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Receives FDA Approval to Launch Next-Generation OCS Heart Trial\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\">2025-08-04 20:02</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      <a href=\"https://laohu8.com/S/TMDX\">TransMedics Group Inc.</a> Receives FDA Approval to Launch Next-Generation OCS Heart Trial\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        TransMedics Group Inc., a medical technology company specializing in organ transplant therapy, announced that it has received conditional approval from the U.S. Food and Drug Administration (FDA) for its Investigational Device Exemption <a href=\"https://laohu8.com/S/IDE\">$(IDE)$</a>. This approval allows TransMedics to initiate its Next-Generation OCS ENHANCE Heart trial. The trial is a two-part clinical study aimed at demonstrating the benefits of prolonged heart perfusion using the OCS™ Heart System and comparing its effectiveness in donation after brain death <a href=\"https://laohu8.com/S/DBD\">$(DBD)$</a> cases to traditional static cold storage methods. With a sample size expected to exceed 650 patients, this trial is set to be the largest heart preservation for transplant trial ever conducted worldwide. This milestone marks a significant step in TransMedics' efforts to transform the standard of care in cardiothoracic transplants.\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. Transmedics Group Inc. published the original content used to generate this news brief via PR Newswire (Ref. ID: NE43286) on August 04, 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":"BK4588","symbol_name":"碎股","start_time":0,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20250804:nNDL2kj9SD:1","article_id":"2556238923","we_media_id":"1032215980","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2556238923","pubTimestamp":1754308933,"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":"TransMedics Group Inc., a medical technology company specializing in organ transplant therapy, announced that it has received conditional approval from the U.S. Food and Drug Administration  for its Investigational Device Exemption . 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