Autorizaciones del INVIMA en proyectos de fabricación de ventiladores para pacientes con COVID-19
Author | Mauricio Patiño/Gerardo Flórez/Vanessa Romero/Diego Quintero |
Position | Socio/Asociado/Especialista/Asociado |
Como consecuencia de las necesidades generadas por la emergencia del Covid-19, la Sala Especializada de Dispositivos Médicos y Reactivos de Diagnóstico In Vitro aprobó el inicio de la fase I del protocolo de investigación “Evaluación clínica del ventilador producto de innovación en Colombia en la pandemia con Sars COVID-19, Unisabana-Herons”.
Las instituciones donde se desarrollará la fase I del protocolo de investigación para los ventiladores mecánicos “Unisabana Herons” son la Clínica Universidad de La Sabana y la Fundación Cardio Infantil – Fundación Neumológica Colombiana.
Igualmente, fue aprobado el inicio de la fase I del proyecto InnspiraMED, en tres modelos de ventilador mecánico estándar.
Estas aprobaciones implican que los protocolos de investigación de ventiladores mecánicos pueden ser utilizado en humanos, en el marco de los estudios clínicos.
Para ampliar la información, puede dirigirse a los siguientes links:
https://www.invima.gov.co/web/guest/el-proyecto-unisabana-herons-obtiene-aprobacion-del-invima-para-iniciar-fase-1-en-humanos?redirect=%2Fweb%2Fguest%2Fnoticias-2020
https://www.invima.gov.co/web/guest/la-sala-especializada-aprueba-el-inicio-del-desarrollo-de-la-fase-1-para-ensayo-en-humanos-del-proyecto-de-ventiladores-mecanicos-innspiramed?redirect=%2Fweb%2Fguest%2Fnoticias-2020
Finalmente, le recordamos que nuestro equipo de abogados se encuentra laborando remotamente desde sus hogares, en los horarios usuales y disponibles a través de todos los medios virtuales para atender y responder a todas sus necesidades.
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