FDA clears the Coala Heart Monitor

Coala Life AB announced in the beginning of 2019 that it has received 510(k) clearance from the Food and Drug Administration (FDA) for the Coala Heart Monitor. The FDA’s clearance opens up for Coala to be sold at the US market.

FDA’s 510(k) clearance of the Coala Heart Monitor is an important performance validation of our unique technology and innovative digital solution. With its mobile and cloud-based solutions, together with its high-performance algorithms, Coala Life are now proud to be able to offer Americans our Coala Heart Monitor.

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