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.
About CardioSTAT
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 (up to 9% of people aged over 65 and 17% of people over 80%) and contributes to more than 140,000 deaths per year with stroke being the leading cause of serious long-term disability in the US(2).
About Icentia
Icentia is a Canadian medical technology company that develops medical devices and operates cardiac diagnostic testing facilities in Canada and the United Kingdom. It is committed to improving cardiac monitoring and accessibility for both patients and physicians, by offering leading edge solutions to major problems in the field of medical testing.
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References
(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 (strokeinfo.org)