Cardio-TriTest
Overview
The Cardio-TriTest v6.5 (CTT) is a 3-in-1 AI-powered diagnostic device developed by Cardio-Phoenix Inc. for the earlier detection of cardiovascular disease. It combines a 12-Lead Electrocardiograph (ECG), a 4 Lead Phonocardiograph (PCG), and a 4 lead Mechanocardiograph (MCG) into a single non-invasive test procedure. The device acquires and synchronizes these three types of bio-signals, outputting them on the same timeline to aid general practitioners in visually determining a patient’s current heart health. This innovative approach aims to help physicians make a broader and more complete diagnosis of cardiovascular health. The technology is designed to detect and diagnose a high percentage of common heart diseases in primary care settings and supports cardiac-telemedicine tools for expanded patient care in remote locations.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Key Features
- 3-in-1 diagnostic device (ECG, PCG, MCG)
- 12-Lead Electrocardiograph (ECG)
- 4 Lead Phonocardiograph (PCG)
- 4 Lead Mechanocardiograph (MCG)
- Synchronized bio-signal acquisition
- Visual correlation of heart bio-signals
- AI-powered analysis for heart disease detection
- Non-invasive test procedure
- Aids in comprehensive cardiovascular diagnosis
- Supports cardiac-telemedicine
Use Cases
- Earlier detection of cardiovascular disease in primary care
- Aid to physicians for broader cardiovascular health diagnosis
- Screening for common heart diseases
- Patient care in remote locations via telemedicine
- Diagnostic interpretation in conjunction with physician over-read
Details
| Category | Cardiology AI |
| Pricing | Contact for pricing |
| Deployment | Clinical setting (device-based) |
| Compliance | |
| BAA Available | Unknown AI-estimated |
| HIPAA Compliant | Yes AI-estimated |
| FDA Status |
1 AI-estimated The Cardio-TriTest v6.5 received FDA 510(k) clearance (K182790) on December 14, 2018. It is classified as a Class II device for Electrocardiograph (21 CFR 870.2340), Ballistocardiograph (21 CFR 870.2320), and Class I for Phonocardiograph (21 CFR 870.2390). The device is intended to provide three different types of non-invasive heart bio-signals as an aid to the physician in making a broader and more complete diagnosis of cardiovascular health. It is indicated for males and females aged 20 years or greater and is not intended for use in pediatrics or intensive care units. |
| Integrations | |
| EHR | Not specified |
| Specialties | Cardiology, Family Medicine, Internal Medicine |
What the Web Says
Cardio-TriTest (CTT) is a non-invasive, 3-in-1 medical device that combines a 12-Lead ECG, a 4-lead Phonocardiograph (PCG), and a 4-lead Miraclecardiograph (MCG) to detect and diagnose a broader range of common heart diseases than traditional ECGs. It has received FDA clearance and is intended for use by physicians in a clinical setting as an aid to diagnosis, not as a sole means of diagnosis. When paired with the Cardio-HART, an AI-based diagnostic and analysis system, it can detect approximately 94% of common heart diseases in primary care, compared to ECG's 44%.
Overall: PositiveStrengths
- Detects a wider range of common heart diseases (94%) compared to ECG (44%).
- Reduces false negative rates by 24.2% and false positive rates by 6.7% compared to ECG.
- Non-invasive and suitable for widespread patient screening in primary care.
- Provides a more holistic view of heart health by synchronizing and correlating ECG, PCG, and MCG bio-signals.
- Validated by clinical studies involving over 15,000 patients.
- Aids physicians in making a broader and more complete diagnosis of cardiovascular health.
Limitations
- Not intended for use in pediatrics or intensive care units.
- Requires physician over-read and consideration of all other relevant patient data for diagnostic interpretation.
- Pricing information is not readily available and requires direct contact.
- Compared to advanced PET/CT imaging systems, its technological innovation in high-end imaging is considered lower.
- May have a more localized deployment compared to enterprise-level adaptable solutions.
- No ratings or extensive reviews found on G2 or Capterra.
Based on reviews from: PRLeap, Physician Ai Tools, accessdata.fda.gov, Healthgrades, PMC, Harvard Health
Last updated: 2026-07-18
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