HOME UTERINE ACTIVITY MONITOR EFFICACY ENDPOINT OF CERVICAL DILATION
This article was originally published in The Gray Sheet
Executive SummaryHOME UTERINE ACTIVITY MONITOR EFFICACY ENDPOINT OF CERVICAL DILATION should remain in FDA's draft premarket testing guidelines for the devices, the agency's Obstetrics and Gynecology Devices Panel recommended at a Sept. 2 meeting in Rockville, Maryland. In a 3-2 vote, the panel said that the measurement of cervical dilation at the time of preterm labor diagnosis should continue to be the primary endpoint in FDA's "benchmark" study design for HUAMs used to diagnose preterm labor.
You may also be interested in...
Switzerland’s SIX exchange-listed drug development company, Basilea, is moving two new oncology candidates along its R&D pipeline, supported by strong revenues from two partnered anti-infective products.
Recommendations from the Alliance for Regenerative Medicine aim to improve cross-border healthcare to ensure patients can access advanced therapies.
At the OurCrowd Global Investor Summit in Jerusalem, Israel, on 13 February, Medtech Insight met wound care device company Nanomedic to find out more about its unique electro-spinning technology.