Icentia CardioSTAT Cleared for Heart Monitoring and Diagnosing

The FDA has granted 510(k) clearance to Icentia’s CardioSTAT, a single-use, wearable electrocardiogram recorder for monitoring and diagnosis of cardiac disorders.

Worn on the upper chest, the lightweight recorder can be worn in the shower. The device, which can monitor patients for up to 14 days and send the data to caregivers, has an accuracy of 99.9 percent, the company said.

Canada-based Icentia develops medical devices and operates cardiac diagnostic testing facilities in Canada and the United Kingdom.

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