Pioneering anaesthesia device receives EU approval
A new device that can enable regional anaesthesia to be performed by just one person has received European CE regulatory approval.
Medovate, a company specialising in anaesthesia, airway management and surgery has developed a device called SAFIRA® (SAFer Injection for Regional Anaesthesia), in collaboration with anaesthetists from the UK's National Health Service (NHS). The company was launched in the UK just over two years ago.
The Class II medical device monitors and limits injection pressure, aiming to improve patient safety by reducing the risk of nerve damage following an injection. Its creators say that it also has the potential to save time and money.
SAFIRA® launched in the US earlier this year after securing FDA clearance. With both CE Mark Approval and FDA Clearance, the device is now ready for markets across Europe and the US. Additionally, earlier this month Medovate signed a distribution agreement with Brisbane-based LTR Medical to make SAFIRA® available in Australia and New Zealand.
Alan Finnerty, Technology Director at Medovate commented: “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.
Stuart Thomson, Managing Director, 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.”