The Future of
ECG Starts
with Us.

The Future of ECG
Starts with Us.

Innovative Simplicity

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.

Our Approach

Commitment to Excellence

We are committed to developing cutting-edge technology for heart monitoring devices, providing the utmost accuracy in diagnostics to save lives.

Simplified Process

We've streamlined the entire process, from device acquisition to reimbursement, ensuring a seamless experience for our partners.

Client-centric
‏‏‎

We understand the unique needs of our clients . Therefore, we deliver high-quality devices prioritizing efficiency, cost savings, simplicity, and exceptional support.

Constantly Evolving

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 Story

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 into 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

Cardea SOLO is a wearable ambulatory ECG system that encompasses it all. With its robust and proprietary software analytics, it is 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.

Cardea SOLO System

SENSOR

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.

SMART CABLE

The smart cable enables USB connectivity to Windows PC and facilitates the seamless transfer of ECG data to the SOLO software.

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.

Competitor Chart

Cardea SOLO

Cardiac insight

Zio®XT & Zio®AT

iRhythm

ePatch™

Phillips

CAM™ Patch

BardyDX

BodyGuardian™ MINI

Boston Scientific

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?

Adults

18 years or older 2

Adolescents

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

1 Zio XT for detecting cardiac arrhythmias (nice.org.uk)

2 K190593.pdf (fda.gov)

3 Zio Monitoring (irhythmtech.com)

4 ePatch_Overall-Brochure_220-0730-01-Rev-A-1.11.21.pdf (gobio.com)

5 ATTACHMENT I (fda.gov), K171410

6 Carnation Ambulatory Monitor Product Brochure (bardydx.com)

7 Ambulatory ECG Monitor Coding & Reimbursement (bardydx.com)

8 Faros Mobile (fda.gov), K182030

9 BodyGuardian MINI Remote Cardiac Monitor – For Physicians (bostonscientific.com)

10 Enhanced-CAM-Report-Overview-050521-DN000344B.pdf (bardydx.com)

11 Holter-Report-Sales-Aid-220-0848-01-Rev.-B-2.7.22-Final.pdf (gobio.com)

12 ePatch – BioTelemetry, a Philips company (gobio.com)

13  Zio Monitoring (irhythmtech.com)

14  Healthcare Professional Support – For Physicians (bostonscientific.com)

15  eCopy K162503-S001.pdf (fda.gov)

16  ATTACHMENT I (fda.gov), K171410

17  K210036.pdf (fda.gov)

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.

Cardea 20/20

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.

Cardea 20/20 System

Reduce False Positives

It provides significantly lower false positives than up to 30% in other devices.

Breakthrough Interpretation

Thanks to the advanced algorithms that meet ANSI/AAMI standards, 20/20’s software analyzes and interprets ECG data with unparalleled precision.

Onsite Testing
‏‏‎ ‎

A lightweight ECG transmitter connects via a USB cable to a standard Windows® PC and can easily be transported to multiple locations.

Let's Talk.

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.

https://doi.org/10.1016/j.jacc.2017.01.015

Innovation Meets Simplicity