Medical device company Medovate has received CE mark approval for its medical device SAFIRA (SAFer Injection for Regional Anaesthesia).
SAFIRA is a new technology that aims to transform regional anaesthesia into a one-person procedure, putting control in the hands of the anaesthetist.
Alan Finnerty, technology director, Medovate 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.”
The Class II medical device provides a 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 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 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.
Stuart Thomson, managing director, Medovate, said: “SAFIRA CE certification is an important leap forward for our company as we continue to expand our footprint and presence globally. The entire Medovate team have worked extremely hard to deliver both US FDA clearance and EU CE approval for this technology within the last six months.
“Our goal is to provide clinicians with an innovative solution to carry out regional anaesthesia procedures effectively at safer pressures. This is especially important in the current healthcare climate which is facing many challenges.”
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. This is because regional anaesthesia preserves respiratory function and avoids aerosolisation and the potential for transmission of COVID-19 compared to general anaesthesia. In enabling regional anaesthesia to be carried out as a one-person procedure, Medovate believes SAFIRA further compliments these recent recommendations.
