The CE Mark is the sign of approval from European regulators, recognised by all Member States of the European Economic Area.
When it comes to highly complicated devices that sustain life like an AED, CE certification is validation that the device meets highest international benchmarks for design, use and safety.
What’s the story behind Rapid Response Revival?
RRR was established in 2017 to improve on the design, portability, cost and ease-of-use of AEDs. In that time, RRR has revolutionised AED technology that before then, had not been improved on in more than 30 years.
The culmination of that work, CellAED was created to improve the chances of survival for people suffering an out-of-hospital cardiac arrest. Globally, more than six million people die every year from sudden cardiac arrest.
While early defibrillation saves lives, more than 80% of these deaths occur in homes. Currently, the cost of AEDs makes ownership of these life-saving devices prohibitive for most households.
This is a major contributor to the low survival rate of out-of-hospital cardiac arrest, which has been estimated to be as low as less than one per cent globally.
CellAED makes AEDs more accessible, portable and easy to use, so that more people can access an AED in those critical first few minutes following an out-of-hospital cardiac arrest.
For every minute without defibrillation and CPR, the chances of being revived following a cardiac arrest drops 10%.
Compared to existing AEDs, CellAED is much smaller and lighter, able to be carried in a handbag or briefcase. Designed to be easy to use under pressure, CellAED’s simple Snap, Peel and Stick instructions allow for faster deployment in an emergency.
CellAED is also fully automated, delivering shocks when they’re needed to keep a patient’s heart beating in the moments it takes before emergency first responders arrive.
RRR’s ground-breaking improvements on current AED technology have also had a significant impact on price. While most AEDs available today cost more than $2,000 each – up to ten times what it will cost to buy a CellAED device.
What are the stakeholders’ views on the certification?
“CE certification is the first regulatory validation that CellAED is a ready solution to the problem of the out-of-hospital cardiac arrest survival gap,” said RRR founder and CEO, Donovan Casey.
“It has taken the relentless efforts of a small outfit in Sydney to tackle the countless challenges involved in creating a small, easy-to-use, low-cost AED. CellAED’s CE certification is proof that we’ve done it, and improved on the decades-old AED technology being used today.”
“CellAED’s CE certification is incredible news for the thousands of emergency first responders, electrocardiologists, first aid trainers and other experts worldwide we have consulted during this process, and who have been waiting for this technology to achieve regulatory approval.”
“The CE Mark is validation that CellAED is needed, and is ready to share with the world,” Mr Casey said. CE Certification is the first regulatory approval secured for the CellAED device.
RRR is seeking regulatory approvals for CellAED in other territories around the world.
While CellAED is not currently available for sale, RRR is preparing a staged rollout in-line with territory regulatory approvals over the next three years.
“RRR is ready to start manufacturing CellAED at scale. We are making preparations to introduce CellAED to territories in the European Economic Area, and other areas within the next year.”
“We started on this journey because we wanted to save lives. With CE, that ambition is one giant step closer to reality,” Mr Casey added.