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Mirvie Granted Breakthrough Device Designation For Test To Identify Risk Of Preeclampsia

 
• By Marion Webb

Mirvie’s RNA platform can identify 75% of women who develop preeclampsia months before symptoms occur.

Pregnant woman
• Source: Shutterstock

Mirvie announced on 3 May it was granted breakthrough device designation from the US Food and Drug Administration for a blood test to indicate a woman’s risk of developing preeclampsia, a complication of pregnancy, before symptoms occur.

The South San Francisco-based company developed the Mirvie RNA platform which analyzes tens of thousands of RNA messages from the...

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Final Curtain For LDTs? FDA Will Not Appeal District Court Decision To Vacate Final Rule

 
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The US FDA has given up on its effort to regulate lab-developed tests as medical devices, at least for now. The agency will not appeal a decision from the Eastern District of Texas that tossed out the FDA’s final rule, leaving the agency with few cards.

More from Policy & Regulation

Permanent FDA Top Lawyer Expected After HHS Counsel Confirmation

 
• By Sue Sutter

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Medtechs Wait For Dividend As UK Spending Review Prioritizes Healthcare And NHS

 
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