The CoroVent pulmonary ventilator, which has been developed by a team of experts headed by Prof. Karel Roubík, from the Faculty of Biomedical Engineering of the Czech Technical University in Prague, has received certification from the FDA (the United States Food and Drug Administration).
The United States government agency FDA has confirmed that the CoroVent pulmonary ventilator has met all the criteria for safety and for its declared purpose.
It has therefore been approved for emergency use in healthcare facilities for treating patients with Covid-19 under conditions set out in the Emergency Use Authorization (EUA). With this certification, CoroVent can be supplied anywhere in the world where the certification is recognized, i.e. outside the borders of the European Union.
“Right from the beginning of the design of the CoroVent ventilator, we of course took into account the need to get this certification. We, therefore, concentrated not only on the functionality of the ventilator, its utility properties and its safety for patients but also on complying with the standards and meeting the requirements for ventilation and healthcare technology in general, including carrying out risk assessments, maintaining detailed technical documentation, keeping records of details of tests and measurements, etc,” Professor Karel Roubík declares.
“With American certification, we can start exporting the equipment. This is a great success for the team of experts headed by Prof. Karel Roubík, for MICo, and also for the communication and diplomatic support team at the CTU rector’s office,” says CTU rector Dr. Vojtěch Petráček.
CoroVent has been doing well on the European level. It won second place in the EUvsVirus hackathon. This was the biggest pan-European online event of its type, which was initiated by the European Commission, together with the European Council for Innovation.
The ventilator also took second place in the Hack the Crisis Czech Republic hackathon, organized by the CzechInvest Agency, which supports entrepreneurship and investment.
CoroVent would not have emerged without the financial support provided by partners in an overall amount of CZK 29 026 000. The collection of funding for the ventilator was organized by the Donio Foundation, thanks to which CZK 22 million was raised within two weeks. CZK 5 million was donated to the project by Coca Cola, via the Red Cross.
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