Coala Life announces today that the US Food & Drug Administration (FDA) has cleared additional indications and uses for the Coala Heart Monitor. The new FDA 510k clearance enables the system to be used for auscultation and monitoring of patients' lungs remotely. The new functionality available is made immediately to existing and new users.
Coala Heart Monitor received its first 510k FDA clearance in 2019. The indication included, among other things, the ability to perform remote smartphone-based ECG with automatic detection of atrial fibrillation and of ability to remotely auscultate the heart.
The new 510k clearance now allows caregivers to use the Coala Heart Monitor and its integrated stethoscope to also monitor and auscultate lungs remotely. The clearance broadens the intended use where the system with its cloud-based care portal can be used by care providers to help detect and monitor various types of lung and respiratory diseases.
"Around 15 million Americans are affected by chronic lung disease (COPD) and the disease mainly affects women. Our new FDA clearance now allows caregivers to use our system to monitor these types of chronically ill patients over longer periods of time in everyday lives. The Coala Heart Monitor now has additional indications within the Remote Patient Monitoring (RPM) reimbursement codes”, comments Dan Pitulia, CEO of Coala Life.
The new FDA-clearance also includes an enhanced ECG algorithm for automatic detection of Atrial Fibrillation (AF) based on RR-variability and P-wave analysis.
Since spring of 2020, the Coala Heart Monitor has been temporarily marketed in the United States for lung auscultation with the support of the FDA's temporary regulations 2020-D-1138-0001 applied under Covid-19. Coala Life has now received permanent FDA clearance for this indication and a unique and new respiratory monitoring solution is immediately available to existing and new Coala users in the United States.