Shalby Arm Gets US FDA Nod for Knee Replacement Device

MT Newswires Live

01/16

Shalby Advanced Technologies (SAT), USA, a step-down subsidiary of Shalby (NSE:SHALBY, BOM:540797) has received approval from the US Food and Drug Administration for its primary total knee replacement device Duraniom, according to a Wednesday filing to the bourses.

The company received "premarket notification clearance" for the total knee replacement device with TiNbN coating.

Based on the safety and effectiveness data, the regulator has determined the device is substantially equivalent to legally marketed predicate devices, the company said.

免责声明：投资有风险，本文并非投资建议，以上内容不应被视为任何金融产品的购买或出售要约、建议或邀请，作者或其他用户的任何相关讨论、评论或帖子也不应被视为此类内容。本文仅供一般参考，不考虑您的个人投资目标、财务状况或需求。TTM对信息的准确性和完整性不承担任何责任或保证，投资者应自行研究并在投资前寻求专业建议。

热议股票

{"basename":"/hans","ssrTDKData":{"titleTemplate":"%s - 老虎证券","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":"老虎证券,老虎证券开户,老虎券商,老虎证券官网,老虎证券app,tigertrade老虎证券,股票,炒股,新加坡股票交易平台,投资,投资理财","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/hans/news/2503037602"},"companyName":"老虎证券"},"pageData":{"isMobile":false,"isTiger":false,"isTTM":true,"region":"SGP","license":"TBSG","edition":"fundamental"},"isCrawlerRequest":true,"__swrFallback__":{"@#url:\"https://stock-news.skytigris.cn/v3/news\",params:#id:\"2503037602\",edition:\"fundamental\",auth_exemption:1,,,undefined,":{"share":"https://ttm.financial/m/news/2503037602?lang=zh_CN&edition=fundamental","thumbnail":"","is_english":true,"pubTime":"2025-01-16 08:25","share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","id":"2503037602","market":"nz","top_or_hot":-1,"title":"Shalby Arm Gets US FDA Nod for Knee Replacement Device","media":"MT Newswires Live","content":"<html><body><p> Shalby Advanced Technologies (SAT), USA, a step-down subsidiary of Shalby (NSE:SHALBY, BOM:540797) has received approval from the US Food and Drug Administration for its primary total knee replacement device Duraniom, according to a Wednesday filing to the bourses.</p><p>The company received \"premarket notification clearance\" for the total knee replacement device with TiNbN coating.</p><p>Based on the safety and effectiveness data, the regulator has determined the device is substantially equivalent to legally marketed predicate devices, the company said.</p></body></html>","source":"mtnewswires_news","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>Shalby Arm Gets US FDA Nod for Knee Replacement Device</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: 11px; color: #7E829C; margin: 0;line-height: 11px;}\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\">\nShalby Arm Gets US FDA Nod for Knee Replacement Device\n</h2>\n\n<h4 class=\"meta\">\n\n\n<a class=\"head\" href=\"https://laohu8.com/wemedia/1092851196\">\n\n\n<div class=\"h-thumb\" style=\"background-image:url(https://community-static.tradeup.com/news/3002d84abbd5ace3c99397c7f95b8d4e);background-size:cover;\"></div>\n\n<div class=\"h-content\">\n<p class=\"h-name\">MT Newswires Live </p>\n<p class=\"h-time\">2025-01-16 08:25</p>\n</div>\n\n</a>\n\n\n</h4>\n\n</header>\n<article>\n<html><body><p> Shalby Advanced Technologies (SAT), USA, a step-down subsidiary of Shalby (NSE:SHALBY, BOM:540797) has received approval from the US Food and Drug Administration for its primary total knee replacement device Duraniom, according to a Wednesday filing to the bourses.</p><p>The company received \"premarket notification clearance\" for the total knee replacement device with TiNbN coating.</p><p>Based on the safety and effectiveness data, the regulator has determined the device is substantially equivalent to legally marketed predicate devices, the company said.</p></body></html>\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"IE00BMPRXN33.USD","symbol_name":"NEUBERGER BERMAN 5G CONNECTIVITY \"A\" (USD) ACC","start_time":0,"source_url":"https://www.mtnewswires.com/","article_id":"2503037602","we_media_id":"1092851196","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2503037602","pubTimestamp":1736987122,"columns":[],"sourceInfo":{"source_id":"mtnewswires_news","name":"MT Newswires"},"weMediaInfo":{"media_name":"MT Newswires Live","introduction":"The most recognized names in North America, Europe and Asia rely on MT Newswires to power their applications. Better news, better service, better price.","home_visible":1,"id":"1092851196","head_image":"https://community-static.tradeup.com/news/3002d84abbd5ace3c99397c7f95b8d4e"},"summary":"Shalby Advanced Technologies , USA, a step-down subsidiary of Shalby  has received approval from the US Food and Drug Administration for its primary total knee replacement device Duraniom, according to a Wednesday filing to the bourses.The company received \"premarket notification clearance\" for the total knee replacement device with TiNbN coating.Based on the safety and effectiveness data, the regulator has determined the device is substantially equivalent to legally marketed predicate devices, the company said.","collect":0,"end_time":0,"defaultTopTitle":"","property":[],"viewcount":null,"language":"en","relate_stocks":{"IE00BMPRXN33.USD":"NEUBERGER BERMAN 5G CONNECTIVITY \"A\" (USD) ACC","BK4141":"半导体产品","IE00BMPRXQ63.HKD":"NEUBERGER BERMAN NEXT GENERATION CONNECTIVITY FUND \"A\" (HKDHDG) ACC","SAT":"SARATOGA INVESTMENT CORP 6% NTS 30/04/27 USD25","BK4543":"AI","LU0348723411.USD":"ALLIANZ GLOBAL HI-TECH GROWTH \"A\" (USD) INC","IE00BMPRXR70.SGD":"Neuberger Berman 5G Connectivity A Acc SGD-H","BK4588":"碎股","BK4585":"ETF&股票定投概念"},"translate_title":"Shalby Arm膝关节置换设备获得美国FDA批准","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"SAT":1},"content_text":"Shalby Advanced Technologies (SAT), USA, a step-down subsidiary of Shalby (NSE:SHALBY, BOM:540797) has received approval from the US Food and Drug Administration for its primary total knee replacement device Duraniom, according to a Wednesday filing to the bourses.The company received \"premarket notification clearance\" for the total knee replacement device with TiNbN coating.Based on the safety and effectiveness data, the regulator has determined the device is substantially equivalent to legally marketed predicate devices, the company said.","kind":"highlight","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"0","news_tag":"","news_rank":0,"symbols":[],"gpt_button":0,"need_auth":false,"code":"91000000","status":"200"}}}