CardioSTAT relies on a wire-free, single-use recorder. Quebec City, Canada-based Icentia called its technology the leading wearable cardiac monitoring solution in Canada. In 2018, it expanded to the UK. According to a news release, CardioSTAT has been prescribed to more than 170,000 patients.
Now, it holds marketing authorization in the U.S., too. Icentia said it enables the company to pursue its mission of “becoming a world leader in ambulatory cardiac monitoring.”
CardioSTAT offers the flexibility of multiple monitoring durations, ranging from 24 hours to 14 days. It features a pay-by-duration model to enable cost savings while addressing clinical needs. The system’s streamlined workflow allows healthcare institutions to perform data analysis themselves with cost-effective proprietary software from Icentia.
“This approval marks a key milestone for our company,” said Pierre Paquet, Icentia co-founder and CEO. “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.”
