Coala heart Monitor

Digital revolution

Real-time cardiac diagnostics

COALA is a unique medical innovation based on more than 10 years of R&D, with more than 20 patents and over 15 industry awards.

A device and cloud-based solution including a high-performance stethoscope, three integrated electrodes to capture diagnostic-quality ECG and smart algorithms enabling real-time analysis of data.

 

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A unique digital solution addressing the needs of modern cardiology

Three reasons for the heart

1. 

INDUSTRY LEADING CAPABILITIES

Real-time analysis of 9 of the most common arrhythmias and P-wave based detection with industry leading accuracy. Integrated stethoscope enabling remote auscultation of heart and lungs. Instant feedback to patient and provider.

2. 

PRESCRIBE UNTIL DIAGNOSIS

Prescribe as 30-day Event Monitor or as a long-term Remote Patient Monitor (RPM) up to a year. Wireless and adhesive-free design improves patient compliance. No waiting for results with on demand ECG reports.

3. 

RISK FREE BUSINESS
MODEL

A scalable system with a pay-per-use business model. No upfront costs or separate license fees. Ideal for telemedicine services with ability to enroll in the clinic or in the safety of the patient’s home. Nominal cost for patient.

Digital revolution

A ground-breaking Swedish innovation

COALA is a unique medical innovation based on more than 10 years of R&D, with more than 20 patents and over 15 industry awards.

A device and cloud-based solution including a high-performance stethoscope, three integrated electrodes to capture diagnostic-quality ECG and smart algorithms enabling real-time analysis of data.

Meeting clinical pain points

Industry leading capabilities

The COALA is designed for real-time remote monitoring of heart and lungs. Real-time ECG analysis with integrated stethoscope enabling remote auscultation of heart and lungs.

Prescribe as a 30-day Event Monitor or as a long-term Remote Patient Monitor (RPM) up to a year. No waiting for results with on demand ECG reports.

Ideal for telemedicine services with ability to enroll in the clinic or in the safety of the patient’s home.

Smart algorithms

The only smartphone system with P-wave based AF detection

The COALA is a CE and FDA 510(k) cleared device supported by strong clinical data with thousands of users. The chest-ECG with synchronized heart sound recording and thumb-ECG is transmitted via Bluetooth to maximize quality, precision and accuracy - with less artifacts and minimized false positives.

COALA’s smart algorithms analyze the recordings based on pattern recognition, P-waves and RR variability. Conventional 1-lead ECGs typically only detect AF based on RR variability, which result in high false positives. The COALA has been proven to be 300% more accurate than standard 1-lead ECG solutions, typically used in watches and other portable ECG’s.

Coala Care Portal

Real-time reports

State-of-the-art 1,000 Hz and 24-bit ECG digital architecture and data analyzed by high-performance cloud-based platform.

The HIPAA-compliant Coala Care portal presents data in real-time to providers and includes a smart report generator with ability to manually annotate and download raw data for further analysis.

Published data has not only proved high sensitivity and specificity for the system, but also a PPV of 87% for automatic AF detection.

Reduce symptoms, anxiety and depression

Clinically proven to improve quality of life

The COALA was used in the groundbreaking RedHeart Study by the Karolinska Institute (Stockholm, Sweden) and included nearly 1,000 women and over 280,000 ECG recordings in everyday life. The study showed an increase in quality of life in women with palpitations, because of the instant results that helped reduce symptoms, anxiety and depression.

The COALA is currently used in multiple clinical studies including the TEASE-study on cryptogenic stroke patients. The COALA is provided to patients to help detect AF post-admission for an extended period of time at home. Results to be presented in 2020.

Woman holding Coala to chest and smiling_square

Integrated stethoscope

Synchronized ECG and heart sounds

COALA has an integrated stethoscope that captures heart sounds. During ECG recordings, the heart sound is recorded and synchronized with the chest measurement. The data is presented as a digital phonocardiogram (PCG) to aid the detection of murmurs.

Heart sounds can also be listened to remotely and downloaded from the Coala Care portal.

Enabling smarter clinical studies

The 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.

The Coala Care portal provides web-based access to real-time patient data with abilities to interpret, annotate and download raw data for further analysis. It’s all Microsoft Azure based with secure storage in the US and Europe.

Read more

Selected studies and product notes

Studies

Study Summary

Summary of clinical studies with the Coala Heart Monitor

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

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

Clinical Protocols
and 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.”

Event Monitoring Protocol

Clinical protocol using Coala Heart Monitor for patient-triggered event monitoring

Post Surgical Procedure Protocol

Real-time remote monitoring pre- and postsurgical procedure with Coala

Ablation Monitoring Protocol

Real-time remote monitoring pre- and postcardiac catheter ablation with Coala

Information

Product Note
Coala Heart Monitor

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

Product Note
COVID-19 expanded indications

Remote diagnostics of multiple arrhythmias. Automatic ECG detection by Coala

Product Note
Remote Respiratory Monitoring

Real-time diagnostics of arrhythmias and remote auscultations of the heart and lungs.

Modality Overview

Monitoring modality overview Coala Heart Monitor

AF ECG

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

Tachycardia ECG

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

Normal ECG

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

Monitoring Report

Example of monitoring report presented in Coala Care Portal

Phonocardiogram

Example of Phonocardiogram presented in Coala Care Portal

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.