Mirvie Receives FDA Breakthrough Device Designation for First Test Designed to Indicate Risk of Preeclampsia Months Before Symptoms Occur
SOUTH SAN FRANCISCO--(BUSINESS WIRE)--Mirvie, a pioneer in predicting unexpected pregnancy complications, today announced the company received U.S. Food and Drug Administration (FDA) Breakthrough Device designation for its test to indicate a woman’s individualized risk of developing preeclampsia before symptoms occur. The test is powered by the proprietary Mirvie RNA platform, which is designed to predict the risk of unexpected complications by revealing the underlying biology of each pregnancy ...