Coala Life, a leading Swedish digital health company has, as supported by FDA’s Emergency Guidance, expanded the indication for use enabling physicians to remotely, in real-time, monitor patients’ hearts and lung sounds.
The Coala Heart Monitor makes it possible for home quarantined patients to easily monitor their heart and record their lung sounds in just 60-seconds while their physicians can remotely read the analyzed data. The small wireless device allows a physician to view a patient’s electrocardiogram (ECG) as well as listen to their respiratory sounds without the patient ever leaving home.
Unlike conventional medical devices that often require hospital-based enrollment, the Coala can easily be activated from the patient’s homes, eliminating the need of patches or wires.
Due to the fast-spreading novel Coronavirus (COVID-19), devices like the Coala Heart Monitor are in high demand in Europe to allow home-based management of high-risk patients with coronary and pulmonary diseases and those of advanced age.
“The Coala device was developed and validated in Sweden based on over ten years of research,” says Coala Life, Inc., founder and president, Philip Siberg. “It truly enables telemedicine with the ability to monitor respiratory sounds and cardiac related conditions in the safety of patient’s homes and help eliminate the need for patient office visits.”
The unique respiratory monitoring solution will be made available by prescription for existing and new Coala users in US and selected EU markets, supported by FDA’s new enforcement policy striving to support patient monitoring during the COVID-19 public health emergency.
“The Coala Heart Monitor was introduced in Scandinavia in 2017 for cardiac patients and only recently in the U.S. The FDA’s new guidance has just enabled us to expand the use for respiratory auscultation as well. The Coala device is smartphone powered with an integrated, high-performance wireless stethoscope, and a synchronous high resolution 2-lead ECG, which allows for real-time remote diagnostics of arrhythmias, forms of congenital heart disease and certain respiratory disorders,” Siberg added.
Source: Company Press Release
