Minute Insight: Thermo Fisher Scientific Wins FDA Clearance For Preeclampsia Blood Test

The FDA cleared Thermo Fisher’s in vitro diagnostic for preeclampsia, the leading cause of pregnancy morbidity and mortality, based on results from the PRAECIS study.

Minute Insight
• Source: Informa/Alamy

Thermo Fisher Scientific is the first company to receive US Food and Drug Administration clearance for a blood test to assess a mother’s risk of severe preeclampsia, the leading cause of pregnancy-related illness and death in the US.

The FDA clearance of these breakthrough biomarkers will have a significant impact on prognosis and treatment for thousands of women at risk for preeclampsia every year in the US, said...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Minute Insights

More from Medtech Insight

Get Ready For International Harmonization Before Approaching QMSR Deadline, Says Regulatory Expert

 

During MD&M East last week, regulatory consultant Darren Reeves reminded device manufacturers that the time to get ready to comply with the new Quality Management System Regulation is now.

Handheld Diagnostics: A Resurging Category That is Here to Stay

 

Handheld diagnostics are more powerful, accessible and clinically relevant than ever. Medtech Insight spoke to companies behind such technologies to learn how they work and discuss their commercial models.

Execs On The Move: 12-23 May 2025

 
• By 

An interactive look at recent executive-level company changes and promotions in the medical device and diagnostics industries.