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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| Format: | Article |
| Language: | English |
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Elsevier
2023-01-01
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| Series: | Revista Médica Clínica Las Condes |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S0716864023000123 |
| Summary: | 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. Resumen: El dispositivo inflable OdonAssist™ para parto vaginal asistido es un dispositivo de investigación que se sometió a pruebas clínicas previas a la comercialización. El plan de generación de evidencia clínica incluye estudios preclínicos y clínicos para respaldar el desarrollo, la aprobación regulatoria y la vigilancia posterior a la comercialización del dispositivo. |
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| ISSN: | 0716-8640 |