The Cardio-TriTest™

A non-invasive diagnostic medical device that captures 3 types of heart bio-signals.

The first version was FDA cleared in June 2015, as K143432.

The latest version was FDA cleared in December 2018, as K182790.

What is CHART?

Cardio-HART™ or CHART, is a cloud-based,
AI powered heart diagnostic processing and
analysis system.

Together with Cardio-Phoenix’s FDA cleared,
non-invasive medical device, CHART
can effectively detect and diagnose a broader
and wider range of cardiac dysfunctions.

Up to 94% of all common heart diseases.

As such, CHART is the ideal system
to effectively enable the widespread screening
for heart disease, even at the Primary Care level.

CHART is designed to integrate into existing
clinical workflows with minimum disruptions or
additional training requirements.

“Early and effective diagnosis of disease onset
plays a major role in determining disease
treatment options, health care costs,
and quality of life.”

WHO.Gov (2017)

The CHART System: Two Main Devices

 

Unified by a clinical management app
that enables and fosters collaboration between primary care physicians
and Cardiologists, including Cardiologist “over-read”.

 

 chart

 

The system has two main elements:

1. The Cardio-TriTest™ (CTT)

An FDA cleared, non-invasive diagnostic medical device
for use in Primary Care or clinical practice.

The device enables the collection of 3-types of bio-signals
including ECG, PCG and breakthrough bio-signal
representative of the heart's physiology.

2. The CHART Processing Algorithm (CPA)¹

A cloud-based, AI powered algorithm
for the analysis and processing of the combined Bio-Signals
for the detection and diagnosis of cardiac dysfunction.

Why CHART matters!

Cardio vascular disease (CVD) is responsible
for more deaths than all cancers combined. Yet
for the patient, detection starts in Primary Care.

…but few patients understand
ECG’s limitations
...and the risks they bring.

Limitations 

ECG can detect only ~44% of common² heart diseases, by prevalence.

Risk

The Risk: 1-out-of-every-2 common heart diseases will either be...

...“missed-diagnosed”, a False-Negative (FN),or

...“mis-diagnosed”, a False-Positive (FP).

 

Harm

  1. Missed-Diagnosed Patients (FN) will believe they are healthy, but are not,
    so won’t engage in their own health.

    Also, patient is denied timely access to appropriate treatment options,
    increasing risk of morbidity or worse.

  2. Mis-diagnosed Patients (FP) could undergo costly and unnecessary testing,
    exposing them to more invasive high risk procedures.

"At 44%, ECG is no longer enough!..."

Using breakthrough bio-signals, powered by the most advanced "AI",

CHART can detect and diagnose a much broader range of cardiac

dysfunctions, anomalies and diseases than ECG alone, thereby

helping clinicians better determine a patients cardiac status.

"...compared to CHART's 94% effectiveness!"

Breakthrough Bio-Signal

CHART effectiveness is due to its breakthrough bio-signal
that can accurately represent the hearts physiology.

And when this breakthrough bio-signal is combined with
ECG and PCG, CHART's overall diagnostic effectiveness
increases to an incredible 94%.

When the heart triggers an electrical spark (ECG),
the resulting heart muscle movements
are captured by this breakthrough Bio-signal.
These same movements are the same seen by Echocardiography.  

A bio-signal based device is ideal for use in Primary Care

 

A heart is like a car motor!

Can your mechanic understand your car’s motor problems
only from the electrical system?

No!

From only the sounds it makes?

No!

They also need to understand the resulting
mechanical movements.

So how can your GP understand heart disease using only ECG?

They try! but...

Missing, is the bio-signal that let's them understand
the heart's movements.

CHART's breakthrough bio-signal
solves this problem.

This is a game changer!

Combined Effectiveness

CHART's effectiveness comes from being able to diagnose
most of the same common heart disease findings
as can also be diagnosed by ECG, ECHO and PCG devices.

Specifically, this includes:

  • 99% of all ECG heart disease findings,
  • 90% of all Echocardiograph (ECHO) heart
    disease findings (which represents ~59%
    of all of the most common heart diseases) and
  • 99% of all auscultation-based heart disease findings or Phonocardiography (PCG).
 

Like merging Three heart diagnostic devices into One

3-devices-in-1

A 12-Lead
Standard ECG

4 x Electronic
Stethoscopes

80% of an
Echocardiograph.

CHART

 
Prevalence of Common Heart Disease Findings by Device
ECG ~44%
ECHO ~59%
ECG + ECHO ~100%
CHAR ~94%

CHART's unique effectiveness comes from combining ECG, PCG
and its breakthrough bio-signal with AI powered algorithms.