Bardy Diagnostics this week said it received CE mark certification for its 14-day version of the Carnation Ambulatory Monitor patch.
The patch is a P=wave centric ambulatory cardiac patch monitor and arrhythmia detection device. It gives clinicians more flexibility to monitor patients over a longer period of time while expanding the portfolio of the company’s existing 2-day and 7-day CAM patches.
“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,” chief operating officer Ed Vertatschitsch said.
Bardy Diagnostics said that the patch gives clinicians the opportunity to detect less frequently occurring arrhythmias to make it better informed decisions. In one study, the BardyDx CAM Patch could identify 40% more arrhythmias and resulted in better, more informed clinical decision-making in 41% of patients when compared to the iRhythm ZioXT patch.
“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,” chief commercial officer Ken Nelson said in a news release.
The company is also expanding its Home Enrollment Program to address the monitoring challenges associated with the COVID-19 pandemic.
“We are all fighting the COVID-19 Pandemic together. To help address the evolving needs of physicians and patients in this public health emergency, facilitate the rapid transition to telehealth for clinics around the country and to ensure uninterrupted access to our CAM patch, our team has worked around the clock to increase our manufacturing capacity and expand our internal business operations to enable patients to receive and apply our disposable, single-use CAM patch at home,” Nelson said. “The home application program eliminates the need for in-person patient and healthcare provider contact, reduces the potential for exposure to COVID-19, streamlines care, and allows healthcare personnel who are already resource-constrained to focus on other areas of critical need.”
Hospitals have already started using the patch to better identify and understand arrhythmias that mean be related to the coronavirus.