The CellAED® is almost production ready, with completed circuitry design and functionality. However, we are now seeking substantial investment to get the product to market quickly, including undertaking the rigorous country specific regulatory testing required.
Our current ambitious goals (in conjunction with our international alliances) are aiming for a December 2018 product release. Each country will have a different time frame for review and assessment and this will determine which country receives the CellAED® products first. Meeting these dates is necessarily reliant on securing the
capital we require within 2017.
Once available to the public, the CellAED® will become readily available from retail stores, including chemists. We also plan to accept orders via our website.
The CellAED® has undergone rigorous circuitry testing during the design stage, followed by simulation testing on calibrated Advanced Life Support (ALS) mannequins and FLUKES™.
These devices confirm that the CellAED® is performing to its specification of measuring a victim’s heart rhythms and dispensing our OPTIMAL™ biphasic waveform shock.
The substantial testing includes;
- Electromagnetic compatibility/electrical safety/performance verification/usability study/reliability/ISTA packaging/drop shock/vibration/temperature/humidity/water proofing.
- Clinical validation trials
- Regulatory certification and registration (TGA, CE marking, FDA, CFDA, KFDA, etc.) of the CellAED® throughout each country which very closely follow these internationally recognised protocols: ANSI/AAMI/ IEC 60601- 2-4:2010/ (R)2015 Medical electrical equipment – Part 2-4: Requirements for basic safety and essential performance of cardiac defibrillators