Bardy Diagnostics (BardyDx) has secured CE mark approval for its 14-day version of the Carnation Ambulatory Monitor (CAM) patch, which is claimed to be the only P-wave centric ambulatory cardiac patch monitor and arrhythmia detection device.
The 14-day CAM patch, which enables clinicians to monitor their patients over a longer period, is added to the already available two-day and seven-day CAM patches.
The company secured 510(k) clearance from the US Food and Drug Administration (FDA) for 14-Day CAM patch in September 2019, as well as clearance from Health Canada in February this year.
Bardy Diagnostics chief operating officer Ed Vertatschitsch said: “CE marking of the 14-Day CAM patch is a significant corporate milestone and a testament to the quality of the CAM patch and BardyDx’s compliance with all applicable European health, safety, performance and environmental requirements.”
Bardy Diagnostics has selected Dot Medical to distribute CAM patch in the UK, while JNC Medical in Canada.
The 14-day CAM patch from Bardy Diagnostics enables clinicians to identify less-frequently occurring arrhythmias
The 14-day CAM patch allows to double the duration of the current seven-day CAM patch, helping clinicians to identify less-frequently occurring arrhythmias, take better decisions and prioritise care.
The company has also announced the expansion of Home Enrollment Programme due to the Covid-19 crisis.
BardyDx has decided to expand the programme to reduce resource burdens on healthcare facilities and risk of exposure of patients and their caregivers to emerging or other infectious diseases.
In March, Bardy Diagnostics announced the use of CAM patch to measure QT segments in COVID-19 patients taking Hydroxychloroquine.
At present, the CAM patch is used in hospital protocols to help physicians better detect and understand arrhythmias that are believed to be associated with Covid-19, including in multiple clinical trials of Covid-19 patients at academic centers across the US who are being treated with Hydroxychloroquine, Azithromycin or both to monitor for QT interval prolongation.
Bardy Diagnostics chief commercial officer Ken Nelson said: “Along with our Health Canada Medical Device License, the ability to distribute a CE-marked 14-CAM patch outside of the United States is one more step towards our P-wave centric detection and analysis technology becoming the global standard of care in long-term cardiac monitoring.”
