Coala Life has announced the expansion of capabilities to help monitor patients from home using the Coala Heart Monitor. This expansion is a result of the US Food and Drug Administration’s (FDA) new Emergency Guidance striving to help battle COVID-19.
The Coala Heart Monitor is an FDA-cleared and CE Class IIa medical device system intended for remote cardiac monitoring using advanced algorithms to detect arrythmias as Atrial Fibrillation (AF). The Coala has also recently been expanded to allow for remote respiratory monitoring with its integrated stethoscope.
Effective immediately, the Coala Heart Monitor will also be able to detect and show ECG results for common arrhythmias such as AV Block II, tachycardia, multiple Premature Atrial Contractions (PACs) and multiple Premature Ventricular Contractions (PVCs).
The new automatic electrocardiogram (ECG) detection algorithms are made available to support remote, real-time patient monitoring during COVID-19 public health emergency, as per the FDA 2020-D-1138 guidance. These additional arrhythmias are available for the duration of the COVID-19 emergency.
“The ability with Coala to monitor patients remotely and obtain real-time ECG analysis of these most common arrhythmias offers progress in the care of patients who are at increased risk of various arrhythmias, some of which are life-threatening. Results are presented on the patient’s smartphone and to the connected healthcare provider in the Coala Care portal,” said Jerome Dwyer, cardiologist and electrophysiologist, of the St Louis Cardiology Center (St Louis, USA).