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CoroVent pulmonary ventilator receives FDA authorization and will be launched on world markets

The CoroVent pulmonary ventilator developed by a team led by Prof. Karel Roubík at the Faculty of Biomedical Engineering CTU in collaboration with partners from COVID19CZ and other experts has received authorization  by the FDA (Food and Drug Administration), which is a very prestigious certificate.

The FDA, a US federal agency, confirmed that the CoroVent pulmonary ventilator manufactured by MICo Group, Třebíč, complies with all safety requirements and the declared purpose. Therefore, it has been approved for emergency use in health care facilities to treat patients with Covid-19 under conditions stipulated in the EUA (Emergency Use Authorization). Thanks to this certificate, CoroVent can be supplied to countries around the world where the authorization is accepted as valid, i.e. outside of the European Union.

“We have of course been aware of the need to certify the CoroVent ventilator ever since we started work on its design. Therefore, we did not focus solely on the ventilator’s functionality, features and patient safety, but also on compliance with standards and requirements on ventilation technology and medical technology in general, including conducting continuous risk analysis, keeping detailed technical documentation, test and measurement protocols, etc. Thanks to this we were able to submit all documents required by the FDA. The meticulous work and our knowledge of the certification process paid off!” says Professor Karel Roubík.

“It’s a great success when just 161 days after its development started at CTU, CoroVent has received a FDA certificate and can be used in the US and everywhere else where the certificate is recognized, i.e. outside of the EU. The US certification means we can start exporting the device. This is a great success for Professor Karel Roubík, MICo and the support communication and diplomatic team at the CTU Rector’s Office,” says doc. Vojtěch Petráček, Rector of CTU. “I also extend my thanks to all partners and donors who participated in the fundraising campaign organized by Donio Foundation. I appreciate the donors’ willingness to help.”

At the end of April 2020, MICo Group started serial production of the ventilator under a CTU licence. “I will not say that the last few weeks have been easy for us, because they haven’t. The fact that we didn’t have the FDA authorization proved to be a major issue and several interesting and lucrative deals fell through because of that. Therefore we made maximum effort together with CTU to obtain the certificate and today, after more than four months of hard work, we can finally say that we have made it,” says Jiří Denner, CEO of MICo Group, whose subsidiary MICo Medical manufactures CoroVent. “Although obtaining the FDA Emergency Use Authorization is absolutely crucial for us, I would not wish to mislead the public. CoroVent is not yet certified for regular use in health care facilities. We have applied for this certification, but it’s a long-distance race, so to say. The device is currently certified for emergency use and in a number of countries this is proof enough that the device is functional and safe,” Mr. Denner comments on the details of the type of certification.

CoroVent has been successful also within the EU. It won the 2nd place at the EUvsVirus hackathon, the biggest online event of its kind led by the European Commission and the European Innovation Council. CoroVent also came second at the Hack the Crisis Czech Republic hackathon organized by the Business and Investment Development Agency CzechInvest. No similar project has been developed in Europe in the past months that would make it to the production and certification stage.

CoroVent would not be possible without financial support from partners in the amount of CZK 29,026,000. The money was collected in a fundraising campaign organized by Donio Foundation that raised CZK 22 million in two weeks; CZK 5 million was donated by Coca Cola through the Red Cross. Thanks to the fundraising campaign and the donors, the devices are ready for immediate use for patients in the Czech Republic in case the pandemic situation got more serious. CTU in Prague would like to thank all donors and contributors.

The Czech Technical University in Prague is one of the largest and oldest engineering universities in Europe. CTU currently comprises eight faculties (Faculty of Civil Engineering, Faculty of Mechanical Engineering, Faculty of Electrical Engineering, Faculty of Nuclear Sciences and Physical Engineering, Faculty of Architecture, Faculty of Transportation Sciences, Faculty of Biomedical Engineering, Faculty of Information Technology) and has over 18,000 students. In the 2020/21 academic year, CTU offers its students 214 accredited study programmes, of which 84 are taught in a foreign language. CTU educates experts in technology, scientists and managers with excellent language skills who are dynamic, flexible and can easily adapt to the labour market requirements.