单分子AD血液检测提交FDA审批!

IVD从业者网
Feb 08

文章来源于IVD工具人,作者IVD工具人Quanterix于2026年2月3日宣布,已向美国食品药品监督管理局(FDA)提交LucentADComplete多指标算法血液检测的510(k)上市前通知。该产品此前已获得FDA突破性医疗器械认定。本次510(k)申报,意味着该检测正从研究与验证阶段,正式迈向临床常规应用路径。多指标+算法,指向AD血液检测的主流方向当前阿尔茨海默病(AD)诊断正在从侵入...

Source Link

Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.

Most Discussed

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