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AmniSure International LLC


30 JFK St Suite 4
Cambridge, MA 2138 United States
Phone:(617) 234-4441
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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.
UMDC Code: 452794
Fax: (617) 661-5617
Email: info@amnisure.com
Website: http://www.amnisure.com
Company Type: Private
Business Started: 2005
Business Lines: Manufacturer/Exporter
Sales Channels: Direct/Distributors
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AmniSure ROM Test Overview
The AmniSure ROM Test is an FDA-cleared diagnostic device (Rx only) that solves a long-standing problem in obstetric practice - diagnosis of Premature Rupture of Membranes (PROM). It is both more accurate and less invasive than the battery of methods currently used to diagnose the same condition.
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Diagnosing Premature Rupture of Membranes
Births that follow spontaneous preterm labor (PTL) and preterm premature rupture of membranes (pPROM) are together designated as spontaneous preterm births. Spontaneous preterm births account for ~70% of all premature deliveries, where the remaining 30% are indicated as a result of maternal or fetal infection.1 Of those births classified as spontaneous preterm births, 64% are the result of preterm labor (PTL) and 36% are the result of preterm premature rupture of membranes (pPROM).
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The AmniSure ROM Test
The AmniSure ROM Test is a diagnostic device that solves a long-standing problem in obstetric practice - accurately diagnosing ruptured fetal membranes (ROM). Premature ROM occurs in about one out of ten pregnancies and constitutes a major factor of both pre and post-natal complications. In the United States, it is estimated that 30% of pregnant women are checked for PROM during pregnancy.
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Product Literature/Brochure:

The AmniSure ROM Test
AmniSure is a rapid test that aids in detecting Rupture Of [fetal] Membranes (ROM) in women with signs and symptoms suggestive of ROM. ROM presents the risks of infection, fetal distress, prolapse of the umbilical cord, postnatal endometritis and abruptio placenta. 1,3 Premature ROM could also lead to premature delivery. All these consequences increase the likelihood of fetal and maternal morbidity and mortality. AmniSure can help diagnose ROM in a timely and accurate manner, so that appropriate and opportune measures can be taken.
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