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. 

Reducing false positives

Proprietary algorithms based on p-wave analysis for AF detection, proven 300% reduction in false positives vs. single-lead ECG.

2. 

Superior diagnostic yield

Patch- and skin-rash free, including an integrated stethoscope. Fully reimbursed, cost-effective solution with no limits in time and use.

3. 

Improving quality of life

Real-time ECG response proven in studies to significantly reduce symptoms and increase quality of life.

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.

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

Cloud based platform

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.

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.

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Selected studies and product notes

Studies

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

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

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.

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 …