Savran Technologies Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to the company’s Urine-based Assay for Early Risk Stratification of Preeclampsia.

The designation underscores the serious unmet need in preeclampsia and highlights the potential of SavranTech’s approach to enable earlier, more actionable risk assessment.

The FDA’s Breakthrough Devices Program is intended to expedite the development and review of certain medical devices that may provide more effective diagnosis or treatment of life-threatening or irreversibly debilitating diseases or conditions.