U.S. Food and Drug Administration Grants Icentia Approval for Revolutionary CardioSTAT® Technology

Icentia Inc. is delighted to announce that CardioSTAT, its ambulatory, continuous ECG monitoring solution relying on a wire free, single-use recorder, has received FDA 510(k) clearance. This opens the door to the world’s largest medical device market, and will have a profound impact on the diagnosis of patients with cardiac disorders in the United States.

Pierre Paquet, co-founder and Chief Executive Officer at Icentia, is confident that CardioSTAT’s cost effectiveness and demonstrated ability to provide effective patient care and outcomes will make a meaningful difference.

CardioSTAT is making waves in the medical field, becoming the leading wearable cardiac monitoring solution in Canada and now in the United Kingdom with an exceptional adoption rate. To date, it has been prescribed to over 170,000 people and Icentia’s mission of becoming a world leader in ambulatory cardiac monitoring has become even more achievable with the clearance to expand to the United States.

CardioSTAT from Icentia stands out from the rest with its unmatched flexibility. Healthcare professionals can select from multiple monitoring durations, ranging from 24 hours to 14 days – all at an affordable cost.

Not only does CardioSTAT provide an efficient ECG data analysis service, but it also enables healthcare institutions and diagnostic facilities to benefit from the streamlined workflow of the single-use recorder – while performing the analysis with Icentia’s cost-effective proprietary software.

About CardioSTAT

The CardioSTAT recorder is an innovative device that offers reliable and long-term monitoring of heart activity. This lightweight, showerproof device can be comfortably worn on the upper chest and record up to 14 days of data with a compliance rate of 99.9%, making it an ideal tool for detecting heart anomalies like atrial fibrillation.

Unfortunately, this condition affects 1-3% of the world population and contributes to more than 140,000 deaths annually, with stroke being the leading cause of serious long-term disability in the US. The CardioSTAT recorder can help identify potential risks and provide medical practitioners with the information they need to save lives.

About Icentia

Icentia is on a mission to revolutionize cardiac monitoring and improve accessibility for both patients and physicians. As a Canadian medical technology company, they develop medical devices and operate cardiac diagnostic testing facilities in Canada and the United Kingdom. Their leading edge solutions are designed to tackle major problems in the field of medical testing, providing patients and their doctors with the best possible care.

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