Icentia Receives U.S. Food and Drug Administration (FDA) Clearance for CardioSTAT
Thursday, April 06, 2023
Icentia Inc., today announced that it has received FDA 510(k) clearance for CardioSTAT, an ambulatory, continuous ECG monitoring solution that relies on a wire free, single-use recorder. "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 United States.", said Pierre Paquet, co-founder and Chief Executive Officer at Icentia.
CardioSTAT has now become the leading wearable cardiac monitoring solution in Canada. Expansion has followed in 2018 with the United Kingdom, where it is experiencing an exceptional adoption rate. To this day, CardioSTAT has been prescribed to more than 170,000 patients. With this clearance, Icentia will be able to pursue its mission of becoming a world leader in ambulatory cardiac monitoring by extending its market to the United States.
The CardioSTAT solution differentiates itself by being the most flexible solution available: 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. In addition to offering an efficient 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 cost effective proprietary software.