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AmniSure®
United States

Overview

AmniSure® is a new diagnostic device developed by N-Dia, Inc. that solves a long-standing problem in obstetric practice - diagnosis of ruptured fetal membranes (ROM). Premature ROM (PROM) occurs in about one out of ten pregnant women and constitutes the major factor of pre-and post-natal complications. In the U.S., at least 30% of pregnant women are checked for PROM during pregnancy.

If the rupture of the amniotic sac that results in the leakage of the fluid is not detected and treated in a timely and accurate manner (within 24 hours from the occurrence of the rupture), infection and other serious complications for the neonate and the mother may occur. Diagnosis of ruptured fetal membranes is of crucial importance at any term in a pregnancy for prompt hospitalization and for timely and proper treatment.

FDA Cleared

Specific, simple, convenient and reliable test, which allows rapid and accurate detection of fetal membranes rupture

Detects miniscule amounts of amniotic fluid in vaginal discharge

No need for speculum examination, additional re-agents or equipment

Results can be evaluated visually

Reliable aid for physicians, the test can also be performed by nurses and midwives

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