Research

Coala Heart Monitor is ideal for clinical studies

Coala Heart Monitor is a medical eco-system that enables groundbreaking clinical studies of the heart. Coala is ideal for user-centered studies and for collecting large amounts of ECG data and heart sounds in geographically distributed groups.

Coala's market-leading performance is clinically evaluated and is based on research findings presented at several national and international research conferences.

As the first integrated smartphone-based system, Coala detects atrial fibrillation by analyzing both P-wave and R-R variability in ECG recordings, according to clinical guidelines. The system also automatically detects a number of other types of arrhythmias and records both chest and thumb ECGs. Coala Life's team continues to develop the system so that more physiological and pathophysiological processes in the heart can be recorded and evaluated.

Advisors

Clinical Advisory Board

Dr.Tord Juhlin , MD, PhD, Chief Physician and Cardiologist, Skåne University Hospital. Dr Juhlin is also chairman of the Swedish Cardiology Association's Heart Rhythm Group (HRG). Dr. Hans-Jörgen Nilsson , MD, PhD, Workstream Lead Cardiology, Chief Physician and Cardiologist, Skåne University Hospital. Dr. Nilsson is involved in the cardiological part regarding the implementation of a new care-information system in Region Skåne. Dr. Claes Held , MD, PhD, Chief Physician and Professor of Cardiology, Uppsala University Hospital. Dr. Held is also a researcher and active at Uppsala Clinical Research Center (UCR).

Read more

Selected studies and product notes

Studies

Study Summary

Summary of clinical studies with the Coala Heart Monitor

Carnlöf, Schenck-Gustafsson, Jensen-Urstad, Insulander. Karolinska Institutet and Karolinska University Hospital

Instant ECG feedback with a new digital technique reduces symptoms caused by palpitations and increases health-related quality of life (the RedHeart study)

European Journal of Cardiovascular Nursing, March 2021

Schenck-Gustafsson, Carnlöf, Jensen-Urstad, Insulander. Karolinska Institutet and Karolinska University Hospital

Improving Efficiency of Clinical Studies Using a Total Digital Approach: Prospective Observational Study

JMIR Formative Research, Feb 2021

Magnusson et al. 2020

Diagnostic yield of chest and thumb ECG after cryptogenic stroke, Transient Electrocardiogram Assessment in Stroke Evaluation (TEASE): a prospective study

BMJ Open, Aug 2020

Magnusson et al. 2020

Patient-reported feasibility of chest and thumb ECG after cryptogenic stroke in Sweden: an observational study

BMJ Open, Aug 2020

Olsson and Samuelsson, 2020

Quality validation of different ECG leads, and an automatic P-wave detection algorithm for AF, based on real-world data

AHA EPI Lifestyle 2020, Phoenix, Arizona

Olsson and Samuelsson, 2020

Real-world data validation of a novel P-wave based automatic Atrial Fibrillation detection algorithm

AHA EPI Lifestyle 2020, Phoenix, Arizona

Insulander, Carnlöf, Schenck-Gustafsson, Jensen-Urstad. Karolinska Institutet and Karolinska University Hospital

Device profile of the Coala Heart Monitor for remote monitoring of the heart rhythm: overview of its efficacy.

Expert Review of Medical Devices https://doi.org/10.1080/17434440.2020.1732814

Carnlöf, Insulander, Jensen-Urstad, Schenck-Gustafsson. Karolinska Institutet and Karolinska University Hospital

Pre-menopausal women with palpatations have more symptoms, anxiety, depression and lower HRQOL than post-menopausal women.

2019, Washington DC

Insulander, Carnlöf, Jensen-Urstad, Schenck-Gustafsson. Karolinska Institutet and Karolinska University Hospital

Symptomatic palpitations causing anxiety in women – what are the underlying arrhythmias?

European Society of Cardiology ESC Congress 2019, Paris, France

Schenck-Gustafsson, Carnlöf, Ljótsson, Insulander. Karolinska Institutet and Karolinska University Hospital

Very rapid inclusion in a clinical study with the help of eAuthentication (Bank-ID). A study on 913 women with palpitations using new digital techniques.

Cardiovascular Spring Meeting (Kardiovaskulära Vårmötet) 2019, Gothenburg

Carnlöf, Schenck-Gustafsson, Jensen-Urstad, Insulander. Karolinska Institutet and Karolinska University Hospital

Instant analysis of the ECG with direct response during palpitations reduce symptoms, anxiety, depression, and increase HRQOL in women

Cardiovascular Spring Meeting (Kardiovaskulära Vårmötet) 2019, Gothenburg

Magnusson P, Samuelsson M et al. 2019

Atrial Fibrillation and the Role of Thumb ECGs

Open Access Book Chapter. http://dx.doi.org/10.5772/intechopen.83660

Olsson and Samuelsson, 2019

Performance evaluation of dual vs. single lead automatic, real-world arrhythmic ECG recordings

European Society of Cardiology ESC Congress 2019, Paris, France

Olsson and Samuelsson, 2019

Evaluation of an enhanced, cloud-based AF-detection algorithm based on real-world arrhythmic recordings

European Society of Cardiology ESC Congress 2019, Paris, France

Olsson and Samuelsson, 2018

Performance evaluation of automatic symptom-ruled,real-world arrhythmic recordings

Cardiovascular Spring Meeting (Kardiovaskulära Vårmötet) 2018, Stockholm

Mattsson, Koyi, Magnusson. Region Gävleborg and Karolinska Institutet

Transient Electrocardiogram Assessment in Stroke Evaluation (TEASE) – rationale and design: a prospective observational study using chest and thumb-ECG

Ongoing

Case studies

Aleris Case Report - Digital arrhythmia assessments with COALA, 2019

“Implementation of the Coala Heart Monitor leads to increased clinical efficiency, lower costs, shorter waiting lists and higher patient satisfaction.”

Information

Product Note - EU version

Coala - First smartphone based system with advanced P-wave detection

Product Note - US version

The first truly patient-engaged and real-time cardiac monitoring system for unlimited use

Example ECG - Coala

Example of chest- and thumb ECG presented with analysis in Coala Care Portal

Data Security overview

Data security and architecture overview Coala Life AB

User manual

Coala Care Portal - an effective web portal for remote ECG analysis

Regulatory

Regulatory and validation support

Coala Life's solutions are all CE Class IIa and FDA 510(k) cleared for home and professional use.

Coala Life ISO/IEC 27001 certificate

Coala Life Information Security Policy

Updates

Research related news

Bild pressrelease EKG Vårmötet

New research confirms Coala’s leading detection accuracy

Gothenburg, April 11, 2019 – New research presented today at the 21st Swedish Cardiovascular Spring Meeting in Gothenburg confirms the detection accuracy of the Coala Heart Monitor and it s sequential combination of digital chest- and thumb-ECG. The 2-lead ECG method and instant cloud-based mobile platform proves significantly increased accuracy of detetcing Atrial Fibrillation as …

Coala-Heart-Monitor-FDA

FDA clears the Coala Heart Monitor

Stockholm, Sweden, February 14th, 2019 – Coala Life AB announced today that it has received 510(k) clearance from the Food and Drug Administration (FDA) for the Coala Heart Monitor. The Coala is a novel mobile and cloud based solution with an integrated electrocardiogram (ECG) and digital stethoscope, ideal for remote monitoring of heart conditions. Coala’s …

Coala+Life+American+Heart+Association+Circulation+

Coala Life presents poster at American Heart Association´s annual meeting (AHA 2018)

Coala Life presented the latest data during the American Heart Association´s Scientific Sessions 2018 (AHA 2018) in Chicago. The annual meeting was held on November 10-12 and is meant to provide a new dimension of cardiovascular discovery and clinical practice for clinicians, basic scientists, and researchers. The poster presented data of Coala´s new analytical algorithms with enhanced functionality, which detects atrial fibrillation based on …

Partners