Icentia Inc., a medical device company offering ambulatory medical testing solutions, today announced it has received Class II Medical Device CE Mark approval for its CardioSTAT continuous ECG monitoring system.
The CE marking confirms that the CardioSTAT system meets the requirements of the European Medical Devices Directive, which now allows Icentia to commercialize the CardioSTAT system in the European Union.
“The CE Mark approval is a significant accomplishment for Icentia as it enables the company to expand its market to the European Union member countries,” says Icentia’s CEO, Pierre Paquet.
CardioSTAT is one of the most efficient cardiac monitoring systems available. Since its official launch in 2015, it has become the leader in its class in Canada.
“The extraordinary success of CardioSTAT across Canada clearly demonstrates that we’ve been able to come up with a highly efficient, yet price competitive solution for public healthcare systems” Paquet says. “We now look forward to allowing European patients to benefit from our technology”.
The CardioSTAT recorder is a unique electrocardiography monitoring device designed to be comfortably worn on the upper chest for up to 14 days by patients with suspected cardiac arrhythmia. It enables healthcare institutions to manage higher volumes of ambulatory ECG tests and reduce lead times to diagnosis, while providing their patients with a greatly improved experience. Quick and easy to install, it avoids the inconvenience and discomfort caused by large-surface skin adhesive patches. The result is a highly efficient, yet comfortable and very discrete, wire-free cardiac monitor that does not restrict patients from showering or doing physical activity.