Published in Women's Health Weekly, September 8th, 1997
The FDA's Center for Devices and Radiological Health accepted the PMA filing for the SalEstTM 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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