Clinical indications expanded by FDA’s Emergency Guidance
to enable more concise home-based ECG monitoring.
Irvine, CA, U.S. — April 28, 2020 /PRN – Coala Life, a world leading pioneer in remote and real-time cardiac monitoring solutions, today announces additional expansion of capabilities to help monitor patients from home. The expansion makes the Coala Heart Monitor the only smartphone-powered ECG solution in the world that automatically detects nine of the most common heart arrhythmias as well as normal sinus rhythm. This expansion is a result of FDA’s new Emergency Guidance striving to help battle COVID-19.
“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, MD, MBA, cardiologist and electrophysiologist, St. Louis Cardiology Center.
The Coala Heart Monitor (“Coala”) 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 (PAC’s) and multiple Premature Ventricular Contractions (PVC’s).
The new automatic electrocardiogram (ECG) detection algorithms are made available as of today 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.
Read product note on Coala Heart Monitor’s expanded indications.
Source: Coala Life Inc.: Philip Siberg, (949) 590-7195
Media Contact: Stephen Jaffe, Jaffe & Co., (310) 275-7327; Cell: 310-713-4849
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