Cardiac Insight, Inc. a privately held medical device company based in Bellevue, WA., is renowned for its cardiac diagnostic products, Cardea SOLO and Cardea 20/20.
It has been providing cardiac evaluations since its first product in 2013. Pioneered by Dr. Dave Hadley and Dr. Vic Frolicher, the Cardea 20/20, a handheld 12-lead ECG device that enhances electrocardiogram reliability for detecting cardiovascular issues in young athletes, is transforming athletic heart care.
In 2017 they introduced the Cardea SOLO, a comfortable, 7-day wearable, ambulatory sensor with software-assisted ECG analysis.
In 2021, Cardiac Insight joined forces with global electronic components leader DreamTech, solidifying their position as a leading innovator in cardiac healthcare diagnostics, poised for exponential growth.
At the heart of Cardiac Insight is a commitment to advancing the development of sensors and algorithms that prioritize accuracy in analyzing high-quality ECG data—a pivotal element in our mission to save lives.
From acquiring a device to reimbursement, we've designed a streamlined process that makes the journey easier for our partners.
The unique needs of our clients remain central to our ethos. Our promise: efficiency, cost-effectiveness, simplicity, and unparalleled support.
Through our unwavering commitment to learning and innovation, we remain dedicated to making ECG analysis more accessible for healthcare providers and patients.
From seismic wave analysis to reshaping cardiac screening, Dr. Hadley’s story is nothing short of exceptional. After earning a Ph.D. at Caltech—and then co-founding Sierra Geophysics—his trajectory took a turn to software before joining forces with Quinton Cardiology.
In collaboration with Dr. Victor Froelicher, Dr. Hadley brought momentum to modern ECG analysis by shaping the “Stanford Criteria” and the life-saving Cardea 20/20. Today, his spirit of innovation thrives as he continues to redefine the boundaries of cardiac care.
Meet Cardea SOLO: an ambulatory ECG system that simplifies the monitoring process. With the ease of recording their ECG from the comfort of their home, and with fast, in-office software analytics, Cardea SOLO generates reports in under five minutes
A feather-light, water-resistant, and wire-free device that continuously records over seven days.
Equipped for USB connectivity to a Windows PC, this cable transfers the ECG data directly to the PC and Cardea SOLO software for analysis
Our software not only generates draft summary reports on-the-fly, but also empowers clinicians with key clinical tools—from trace and R.R. view to beat morphologies and calipers.
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)
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
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%, the Cardea 20/20 ECG stands as a leader in automated 12-lead ECG systems. Its life-saving purpose? To prevent sudden cardiac issues by identifying cardiac conditions in active youth and athletes using the International Consensus Criteria1.
Our device registers strikingly fewer false positives compared to the 30% rate seen in some other devices.
Advanced algorithms that adhere to ANSI/AAMI standards ensure the 20/20’s software can interpret ECG data with precision.
Our lightweight ECG transmitter is designed for easy connectivity to a standard Windows PC and can be effortlessly transitioned across 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.
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