September 17, 2020
SAFIRA ® (SAFer Injection for Regional Anaesthesia) has received CE Mark Approval. The news was announced today by Medovate.
SAFIRA ® is a revolutionary new technology that transforms regional anesthesia into a one-person procedure, putting control in the hands of the anesthetist.
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 modeling shows it has the potential to generate significant time and cost savings.
Developed in collaboration with anesthetists in the UK National Health Service (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.
Alan Finnerty, Technology Director, 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 anesthesia procedures, as well as generate unique cost optimization benefits for healthcare.”
Stuart Thomson, Managing Director, Medovate commented “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 has 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 anesthesia 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 anesthesia should be preferred over general anesthesia whenever surgery is planned for suspected or confirmed COVID-19 patients.
This is because regional anesthesia, which involves numbing only the area of the body that requires surgery, preserves respiratory function and avoids aerosolization and the potential for transmission of COVID-19 compared to general anesthesia. In enabling regional anesthesia to be carried out as a one-person procedure, Medovate’s innovative technology, SAFIRA®, further compliments these recent recommendations.
Now, with both CE Mark Approval and FDA Clearance, SAFIRA® can be readily integrated into healthcare markets across Europe and the US.