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BEDFORD, Mass.–(BUSINESS WIRE)–Rejoni, Inc., a clinical-stage company focused on uterine health, today announced that the U.S. Food and Drug Administration (FDA) has completed its filing review and formally filed the Premarket Approval (PMA) application for the Juveena Hydrogel System. In its filing notification, FDA stated that the submission contains the information needed to proceed with substantive review. The Juveena Hydrogel System is designed as a temporary spacer to help prevent the f