Generating the clinical evidence for an innovation in maternal and newborn health: The OdonAssist™ inflatable device for assisted vaginal birth

The OdonAssist™ inflatable device for assisted vaginal birth is an investigational device which underwent premarket clinical testing. The clinical evidence generation plan includes preclinical and clinical studies to support development, regulatory approval and post market surveillance of the device...

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Bibliographic Details
Main Author: Mario Merialdi
Format: Article
Language:English
Published: Elsevier 2023-01-01
Series:Revista Médica Clínica Las Condes
Subjects:
Online Access:http://www.sciencedirect.com/science/article/pii/S0716864023000123