Obstetrics (Screening)

Biex PMA Accepted for Filing by FDA

Published in Women's Health Weekly, September 8th, 1997

Biex Inc. has announced that the Food and Drug Administration (FDA) has granted expedited review of the company's application for premarket approval (PMA) of its test for identifying women at risk for preterm labor and delivery.

The FDA's Center for Devices and Radiological Health accepted the PMA filing for the SalEst^TM system, indicating that accelerated review is warranted because the test "provides for clinically important earlier diagnosis over existing alternatives for risk assessment of spontaneous preterm labor and preterm delivery."

The company noted that the application was accepted for filing only 29 days after it was submitted...

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Source: Women's Health Weekly (1997-09-08)

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