FDA OKs CardioSTAT Continuous, Ambulatory ECG Recorder

Icentia has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for CardioSTAT, an ambulatory, continuous ECG monitoring solution that leverages a wire-free, single-use recorder.
 
According to the company, CardioSTAT has become the leading wearable cardiac monitoring solution in Canada. Expansion followed in 2018 with the UK, and to this day the device has been prescribed to over 170,000 patients.
 
“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,” Pierre Paquet, co-founder and CEO of Icentia told the press.
 
The flexible, lightweight, showerproof CardioSTAT recorder is worn on the upper chest and records up to 14 days of ECG data. This lets clinicians spot heart anomalies that are usually difficult to identify, like atrial fibrillation.
 
CardioSTAT has multiple monitoring durations ranging from 24 hours to 12 days. A “pay by duration” model, according to Icentia, can show cost savings and address a wide range of clinical needs. Data analysis can be performed by the user thanks to Icentia’s proprietary software, or users can leverage Icentia’s ECG analysis service.