Feedback to EMA request related to a comment about a prototype of ActiMyo

The current version of ActiMyo, commercialized by Sysnav, is a CE marked medical device. It is designed to fulfil home monitoring constraints and is tested in lab and in a home setting.

During its development, several prototyped versions were manufactured. One of the prototyped versions could heat up in its docking station and may result in the battery to inflate after several weeks of charging cycles. This known phenomenon for this type of medical batteries induces reduced battery life. These prototyped devices are still safe. The current product which is qualified as CE marked medical device corrects this limitation.

This public statement gives the ActiMyo team the opportunity to re-iterate the importance to raise any concern or adverse event and to remind that it is particularly important to use ActiMyo as instructed ( Any concern or adverse event is worth mentioning and can be reported at