RESPIRA project has been developed under the supervision of Institut Català de la Salut (ICS) of the Government of Catalonia, with the cooperation of Hospital Clínic de Barcelona and Centre de Medicina Comparativa i Bioimatge del Institut de Recerca Germans Trias i Pujol - Can Ruti de Badalona, and with physicians from Hospital de Sant Joan de Déu de Barcelona. Moreover, the project has been developed in collaboration with Technology in Biomaterials (TiB). Following the classification rules provided by the Medical Device Regulation MDR 2017/745, the medical device RESPIRA has been catalogued as class IIb.
The medical device has overcomed a wide range of validation tests such as software, mechanical tests and biocompatibility, as well as acoustic, electromagnetic suscpetibility, electrical safety and vibrations and shocks, Applus certified. Furthermore, preclinical studies with adult and pediatric porcine models have been fulfilled.
In April 2020, the Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) of the Spanish Health Ministry authorized the use of the medical device in hospitals as a clinical study, which has enabled its use in patients suffering from COVID-19 during the emergency health situation. From these studies, the performance of the device has been analysed, obtaining excelent results in patients susceptible of reciving treatment with RESPIRA. Nowadays, the invasive mechanical ventilator RESPIRA device.com Advanced is under the process of obtaining the CE marking, FDA, as well as addicional certifications mandatory for the use of the device in distinct geographical areas.