Medovate and its Saudi Arabia based distributor AKSIA Healthcare have secured SFDA (Saudi Food and Drug Authority) Approval for the SAFIRA (SAFer Injection for Regional Anaesthesia) device.
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This is the fifth regulatory approval secured by the Cambridge based medical device manufacturer which is dedicated to the development and commercialisation of innovative medical technologies from within the NHS. Having secured SFDA Approval the company can now start selling the pioneering device in the Kingdom of Saudi Arabia, the biggest market in Middle East.
The SAFIRA system is a revolutionary new technology that can transform regional anaesthesia into a one-person procedure and gives the anaesthesiologist full control of the regional anaesthesia process without the need for an assistant. It also incorporates a built-in safety system to automatically limit injection pressure, reducing the risk of nerve damage and enhancing patient safety.
The SAFIRA system already has FDA clearance in the US, European CE mark certification, HSA Approval in Singapore and TGA approval in Australia.
Alan Finnerty, technology director at Medovate, said: “This latest regulatory approval for SAFIRA is another significant step forward in bringing this revolutionary technology, developed in collaboration with clinical innovators from within the NHS, to market on a global scale. We are excited to now be able to make the benefits of the SAFIRA system for safer regional anaesthesia available across Saudi Arabia and we believe approvals will now soon follow in Bahrain, the UAE and Kuwait. We believe SAFIRA has the potential to transform the regional anaesthesia landscape and are committed to ensuring its global commercial availability working alongside our distributor partners including AKSIA Healthcare.”
Ahmed Sallam, managing director of AKSIA Healthcare FZC, added: “The SAFIRA system is a game-changing technology for regional anaesthesia which has the potential to deliver real patient safety benefits for anaesthesiologists and their patients. AKSIA Healthcare is delighted to be Medovate’s distributor partner and the whole team is excited to now be able to start full roll out of this innovative technology to hospitals throughout Saudi Arabia.”
SAFIRA has been exhibited at medtech events including a live demonstration at Arab Health 2022 by one of the co-inventors Dr Emad Fawzy, a consultant anaesthesiologist, at the Sheikh Khalifa Medical City in Abu Dhabi.
Dr Fawzy said: “There is already significant interest amongst Middle Eastern clinicians in this new technology for safer injection for regional anaesthesia. I am delighted that SFDA regulatory approval has been secured enabling AKSIA Healthcare to begin activities to secure wide adoption of the SAFIRA system across Saudi Arabia. This is a proud moment for myself and my co-inventors.”
The technology has received positive feedback from clinicians across the globe who have used the pioneering technology. A multi-centre Post Market Clinical Follow Up (PMCF) Study has been completed and results will be published later this year which will help to further demonstrate the potential patient safety and cost optimisation benefits of the SAFIRA system.
As regional anaesthesia can deliver benefits for both patients and healthcare providers, demand for such procedures continues to grow steadily, and SAFIRA has the potential to make a significant impact, including in the Middle East. In Saudi Arabia in 2020 there were just under 3,500 practicing anaesthesiologists and research conducted in 2012 showed 88% of anaesthesiologists in Saudi Arabia were practising regional anaesthesia daily. The global ultrasound guided regional anaesthesia market is growing and is forecast to register a CAGR of 5.8% through to 2028.
