Personal defibrillator gains CE certification

A Sydney-based medical device start-up, Rapid Response Revival (RRR), has secured European regulatory approval for its personal automated external defibrillator (AED), CellAED.

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 the highest international benchmarks for design, use and safety.

Since the company’s establishment, RRR has revolutionised AED technology, with the culmination of work resulting in the creation of CellAED 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 1% globally.

CellAED was created to make AEDs more accessible, portable and easy to use, so that more people have access to 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, so much so that it can 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 fast 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.

Most AEDs available today cost more than $2000 each — up to 10 times what it will cost to buy a CellAED device.

“Achieving 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,” RRR founder and CEO Donovan Casey said.

“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 around the world we have consulted during this process, and who have been waiting for this technology to achieve regulatory approval.

“For all of us, the CE mark is validation that CellAED is needed, and is ready to share with the world,” Casey said.

RRR is in the process of 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.