Regulatory information

Regulatory information

Veye Chest (Aidence) is CE marked as class IIb under the new medical device regulations (October 2020).

icolung (icometrix) is a CE-marked class I medical device (May 2020).

Veolity (MeVis) is a CE-marked class IIa medical device (May 2014).

The following manufacturer field safety notices or medical device alerts for this technology have been identified.

Veye Chest (Aidence): it was noted that there was a bug in the software that was introduced with the release of Veye Chest 2.6.0. Aidence released a fix to address the bug. Medicines and Healthcare products Regulatory Agency reference: 2019/011/019/291/017.