Icentia announces that it has received U.S. FDA 510(k) clearance for CardioSTAT, an ambulatory, continuous ECG monitoring solution that relies on a wireless, single-use recorder. 

The CardioSTAT recorder is a flexible, lightweight, and showerproof device designed to be comfortably worn on the upper chest. It can record up to 14 days of data with a compliance rate of 99,9%(1). This enables medical practitioners to detect heart anomalies that are generally difficult to identify, such as atrial fibrillation, which affects from 1% to 3% of the world population and contributes to more than 140,000 deaths per year with stroke being the leading cause of serious long-term disability in the U.S.(2)

“This approval marks a key milestone for our company. The FDA clearance opens the door to the world’s largest medical device market,” says Pierre Paquet, co-founder and CEO at Icentia. “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 is a leading wearable cardiac monitoring solution in Canada, the company says. Expansion followed in 2018 with the United Kingdom. According to Icentia, CardioSTAT has been prescribed to more than 170,000 patients. 

With the CardioSTAT solution, physicians have a choice of multiple monitoring durations ranging from 24 hours to 14 days. The pay-by-duration model enables healthcare professionals to demonstrate cost savings while addressing a wide range of clinical needs, the company says. In addition to offering an ECG data analysis service, Icentia also provides the ability for healthcare institutions and diagnostic facilities to benefit from the streamlined workflow of the CardioSTAT single-use recorder while performing the data analysis themselves using Icentia’s proprietary software.


  1. Internal data collected on more than 90,000 patients, Icentia Inc. 2018-2021
  2. Stroke awareness foundation, facts and statistics Stroke Facts & Statistics – Stroke Awareness Foundation (