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

The wire-free and single-use CardioSTAT recorder is a flexible, lightweight, and showerproof device, which can be easily worn on the upper chest for cardiac monitoring.

Icentia co-founder and CEO Pierre Paquet said: “This approval marks a key milestone for our company. 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 US.”

CardioSTAT has the potential to provide up to 14 days of continuous ECG recording and analysis  with a compliance rate of 99.9%.

Offering multiple options in terms of monitoring durations ranging between 24 hours and 14 days, the device helps healthcare professionals address a wide range of clinical requirements through pay by duration model.

Medical practitioners can use the device to detect difficult-to-identify heart anomalies, including atrial fibrillation.

The FDA clearance of the device will allow the company to expand its market to the US.

CardioSTAT is claimed to be among the leading wearable cardiac monitoring devices in Canada. The company expanded to the UK market in 2018. More than 170,000 devices have been distributed to date.                                                                                                                

Icentia, which is involved in the development of medical devices, has cardiac diagnostic testing facilities in Canada and the UK.