Cardiac Insight began the development of the revolutionary Solo ECG interpretative system in 2015. This smart device received FDA clearance in 2017, and we soon introduced it to the market.
This game-changing solution provides a comprehensive cardiac evaluation over a 7-day wear period and is fully reimbursable with global billing, ensuring accessibility for all patients.
Dr. Dave Hadley and Dr. Vic Frolicher joined their expertise to create the Cardea 20/20 ECG™ system and add a new dimension to caring for the athletic heart.
We are committed to developing cutting-edge technology for heart monitoring devices, providing the utmost accuracy in diagnostics to save lives.
We've streamlined the entire process, from device acquisition to reimbursement, ensuring a seamless experience for our partners.
We understand the unique needs of our clients. Therefore, we deliver high-quality devices prioritizing efficiency, cost savings, simplicity, and exceptional support.
Our dedication to learning, adapting, and embracing innovation enables us to effectively assist healthcare providers and patients and make ECG diagnostics accessible.
Dr. Hadley’s journey has been extraordinary, from pioneering seismic wave analysis to revolutionizing cardiac screening. It all started with earning a Ph.D. at Caltech and co-founding Sierra Geophysics.
He transitioned to a software company, where he was very successful. Eventually, he joined Quinton Cardiology. Collaborating with Dr. Victor Froelicher, he significantly contributed to ECG analysis, leading to the “Stanford Criteria” and the life-saving Cardea 20/20. Today, working on our latest innovation, he continues to push boundaries in the cardiac care industry.
Cardea SOLO is a wearable ambulatory ECG system that encompasses it all. With its robust and proprietary software analytics, it was created to simplify the diagnostic process. It offers comfortable at-home recording, automated in-office software, and fast reporting with over 96% accuracy. Cardea SOLO ensures results in less than 5 minutes.
SENSOR is a lightweight (23g), water-resistant, and wire-free device with a 7-day wear period. It can continuously record up to a million heartbeats.
The smart cable enables USB connectivity to Windows PC and facilitates the seamless transfer of ECG data to the SOLO software.
Our software provides immediate ECG data access, automatically generating draft summary reports. It also offers a range of powerful clinical tools, including trace view, R.R. view, beat morphologies, and calipers.
Zio®XT & Zio®AT
Prescribe wear period
Provides interpretive findings
Yes, provided by the software
Yes, provided by software by a diagnostic service provider facilitated by proprietary software
Full narrative summaries 12 are provided by a diagnostic service provider
Findings summary 10 provided by a diagnostic service provider or by your trained clinical staff
No interpretive statements. 8 Computer-generated analysis provided by diagnostic service provider.
Provides full disclosure
Yes, two clicks to see any heartbeat
Only available by request 1 to a diagnostic service provider
Limited to event data 4
from a diagnostic service provider
Yes 6 from a diagnostic service provider
Limited to arrhythmia events 8 from a diagnostic service provider
Who owns the data?
You do, the prescribing physician.
The diagnostic service provider1
The diagnostic service provider4
Can be the diagnostic service provider or the prescribing physician6
The diagnostic service provider
Clinical analysis of data
So fast it can be done in-office at time of patient visit
Requires diagnostic service provider 1
Requires diagnostic service provider4
Option to use diagnostic service provider or your trained clinical staff 6
Requires diagnostic service provider 14
Who can wear it?
18 years or older 2
18-21 years and adults 5
Includes pediatric indication (not weighing less than 10 kg) 7
Includes pediatric indication (not weighing less than 10 kg) 8
Report turnaround time
Can be done in-office during patient visit
4 days maximum but usually 24-hours1
(depending on SLA* agreement and location in queue)
Posted in less than 48 hours 11
(depending on SLA* agreement and location in queue)
Option to use diagnostic service with 2-day turnaround time
(depending on SLA* agreement and location in queue) or your trained clinical staff 6
Depends on SLA* agreement and location in queue of diagnostic service provider.
*Service level agreement
5 ATTACHMENT I (fda.gov), K171410
8 Faros Mobile (fda.gov), K182030
16 ATTACHMENT I (fda.gov), K171410
All online references retrieved 28 July2023
All trademarks are the property of their respective owners.
*Reference: Turakhia, M.P., Hoang, D.D., Zimetbaum, P., Miller, J.D., Froelicher, V.F., Kumar, U.N., Xu, X.Y., Yang, F., Heidenreich, P.A. (2013). Diagnostic utility of a novel leadless arrhythmia monitoring device. American Journal of Cardiology 112(4), 520-524. **Longer if outsourced
Comparative product Information is for convenience and general information purposes only. It is obtained from publicly available, third-party sources and is subject to error, omission, or change without notice. Cardiac Insight makes no representation of its suitability for any purpose. Refer to individual manufacturer documentation for more information.
With the industry’s lowest false-positive rate of ~2%, Cardea 20/20 ECG is a reliable automated 12-lead ECG system for identifying cardiac conditions using the International Consensus Criteria1 related to sudden cardiac death in active youth and athletes.
It provides significantly lower false positives than up to 30% in other devices.
Thanks to the advanced algorithms that meet ANSI/AAMI standards, 20/20’s software analyzes and interprets ECG data with unparalleled precision.
A lightweight ECG transmitter connects via a USB cable to a standard Windows® PC and can easily be transported to multiple locations.
1 Sharma S, Drezner J, Baggish A, et al. International Recommendations for Electrocardiographic Interpretation in Athletes. J Am Coll Cardiol. 2017 Feb, 69 (8) 1057–1075.