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.
A unique digital solution addressing the needs of modern cardiology
Three reasons for the heart
1.
Patch-free and easy to use
Patient friendly design with integrated ECG electrodes and stethoscope.
No limits in time or use.
Office or home based enrollment.
2.
Superior diagnostic yield
Cloud-based analysis by smart algorithms. AF detection based on p-waves, proven 300% reduction in false positives vs.
single-lead ECG.
3.
Reimbursed and affordable
Prescribe and bill as Event Monitor or long-term Remote Patient Monitor (RPM). Provider pays per use.
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.
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.
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
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
Tachycardia ECG
Example of chest- and thumb ECG presented with analysis in Coala Care Portal
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.
Regulatory
Regulatory and validation support
Coala Life's solutions are all CE Class IIa and FDA 510(k) cleared for home and professional use.
