Medovate and its Singapore-based distributor Bluestone Corporation Pte have secured Singapore’s Health Sciences Authority (HSA) approval for the SAFIRA (SAFer Injection for Regional Anaesthesia) system.
The regulatory approval means the UK based company - dedicated to the development and commercialisation of innovative medical technologies from within the NHS - can immediately market the pioneering device in Singapore. It represents the first regulatory approval for Medovate and SAFIRA in Asia and adds to existing approvals in the United States, Europe, Australia, and New Zealand.
Developed in collaboration with clinicians from the National Health Service (NHS) in the UK, the award-winning SAFIRA system is a revolutionary Class II medical device set to transform regional anaesthesia around the world by making it a one-person procedure. The system also helps to improve patient safety by helping to reduce the risk of nerve injury by automatically limiting injection pressure to a specified threshold.
Working with Bluestone – the appointed SAFIRA distributor for Singapore – the latest regulatory approval will allow Medovate to bring the benefits of their ground-breaking technology to an additional continent and community of clinicians in Asia.
Chris Rogers, sales and marketing director, Medovate, said: “Asia is an important market for Medovate. Successfully securing HSA approval reflects our mission to make regional anaesthesia safer globally and enables us to maximise the reach of SAFIRA. This approval is another milestone and will enable us to build on our momentum and presence in Asia and worldwide to meet the increasing demand for regional anaesthesia. As our first distribution partner in Asia, we are delighted to be working with Bluestone to bring the many benefits of SAFIRA to a new community of patients and clinicians in Singapore.”
David Loh, director at Bluestone Corporation Pte, added: “We are proud to be given this great opportunity in partnering Medovate to bring this exciting technology to Singapore. SAFIRA will bring not only great clinical benefits to our clinicians, it will also improve on clinical outcomes and patients’ safety.”
Recent studies have sparked new enthusiasm for regional anaesthesia across the world with evidence indicating improved clinical outcomes. During the COVID-19 pandemic, the European and American Societies of Regional Anesthesia both produced joint COVID-19 recommendations stating that regional anaesthesia should be considered over general anaesthesia if appropriate, as the need to minimise aerosol-generating procedures (AGPs) took precedence.
As demand for surgical procedures increases globally, the SAFIRA system – which turns regional anaesthesia into a one-person procedure – could have an impact in areas such as Asia, where the anaesthesia devices market, particularly in the Asia Pacific region, is set to experience further growth.
The SAFIRA system, Medovate’s first technology to be brought to market, has also successfully secured FDA clearance and European CE mark certification. The system additionally has both TGA (Therapeutic Goods Administration) Approval in Australia and inclusion on the WAND Database in New Zealand.
