Imricor Medical Systems Submits Mapping System to US FDA for Pediatric Label Expansion

MT Newswires Live
04/08

Imricor Medical Systems (ASX:IMR) submitted its NorthStar 3D mapping and guidance system to the US Food and Drug Administration (FDA) for pediatric label expansion through the Special 510(k) program, according to a Wednesday filing with the Australian bourse.

The expansion is intended to support the establishment of an installed base in pediatric centers in the US, the filing said.

NorthStar had received FDA clearance for the use of the system in adult patients, as disclosed in January, per the filing.

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. 1
     
     
     
     
  2. 2
     
     
     
     
  3. 3
     
     
     
     
  4. 4
     
     
     
     
  5. 5
     
     
     
     
  6. 6
     
     
     
     
  7. 7
     
     
     
     
  8. 8
     
     
     
     
  9. 9
     
     
     
     
  10. 10