Medovate’s SAFIRA receives European CE regulatory approval
Medovate has announced that it has received the CE Mark Approval for its SAFIRA (SAFer Injection for Regional Anaesthesia) medical device.
SAFIRA is a new technology that transforms regional anaesthesia into a one-person procedure, putting control in the hands of the anaesthetist.
The Class II medical device provides a unique safety solution that monitors and limits injection pressure, helping to improve patient safety by reducing the risk of nerve damage following injection. In addition, economic modelling shows it has the potential to generate significant time and cost savings.
Developed in collaboration with anaesthetists in the UK NHS, the device was successfully launched in the US earlier this year, having secured FDA clearance, bringing Medovate’s first medtech innovation to market.
Successful CE certification marks a key milestone for the fast-growing company, itself established just over two years ago. As a UK-based enterprise, this regulatory approval is essential as it continues to expand in territories across the world.
Technology Director Alan Finnerty said: “We are thrilled to announce CE mark approval for our pioneering technology. Given the significant benefits SAFIRA brings to both clinicians and patients, we are confident that our ability to enter the European market will help deliver improved outcomes for patients undergoing regional anaesthesia procedures, as well as generate unique cost optimisation benefits for healthcare.
MD Stuart Thomson added: “SAFIRA CE certification is an important leap forward for our company as we continue to expand our footprint and presence globally … Our goal is to provide clinicians with an innovative solution to carry out regional anaesthesia procedures effectively at safer pressures.”
The European and American Societies of Regional Anaesthesia have recently produced joint COVID-19 recommendations stating that regional anaesthesia should be preferred over general anaesthesia whenever surgery is planned for suspected or confirmed COVID-19 patients. In enabling regional anaesthesia to be carried out as a one-person procedure, SAFIRA further complements these recent recommendations.