Icentia has secured the 510(k) clearance for its ambulatory, continuous electrocardiogram (ECG) monitoring solution CardioSTAT from the US Food and Drug Administration (FDA).

According to the Canadian medical technology company, its ECG monitoring solution is wireless and uses a single-use recorder.

The company stated that CardioSTAT is flexible, lightweight, and showerproof, which can be worn on the upper chest. The device can record data for up to 14 days.

By using the cardiac monitoring solution, medical practitioners can identify heart anomalies such as atrial fibrillation and others that are usually difficult to identify.

Icentia co-founder and CEO Pierre Paquet said: “The FDA clearance opens the door to the world’s largest medical device market.

“With the cost effectiveness and demonstrated ability of our cardiac monitoring solution to provide effective patient care and outcomes, we have no doubts that CardioSTAT will make a meaningful difference in the diagnosis of patients with cardiac disorders in the United States.”

CardioSTAT, which was first launched in Canada in 2015, was introduced in the UK in 2018.

Icentia said that the wearable cardiac monitoring solution gives physicians an option of various monitoring durations that range from 24 hours to 14 days.

It is available via a pay by duration model which is said to help healthcare professionals drive cost savings while addressing a variety of clinical requirements.

Apart from offering ECG data analysis service, Icentia, through the device, offers a streamlined workflow of the single-use recorder while carrying out the data analysis themselves using the company’s proprietary software.