The CardioANS™ device, an FDA-cleared Class II medical device, is ideal for assessing heart failure (HF) and monitoring arterial hardening, circulation, heart rate variability (HRV), and autonomic nervous system function. Identify patients with hypertension, diabetes, hormone replacement therapy (HRT), and individuals who had COVID-19. The CardioANS enables baseline assessments and provides comparative insights every 90-days, allowing healthcare providers to track progress, adjust treatments, and improve patient outcomes effectively.

Our CardioANS™ assessment measures the left ventricle and can be performed by a medical assistant to aid in diagnosing heart failure (HF), providing real-time results.

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Identify Cardiovascular Risks

Diabetic Cardiomyopathy is a disorder of the heart muscle in people with diabetes. Diabetic cardiomyopathy is a condition where diabetes adversely affects the structure and function of the heart muscle. While traditional cardiovascular diseases are often associated with conditions like high blood pressure or atherosclerosis, diabetic cardiomyopathy occurs independently of these factors. Patients with diabetes Type 2 have up to a 74% increased risk of developing Heart Failure (HF), and diabetic patients with HF are 4x more likely to die than those without HF. Importantly, unrecognized HF is highly prevalent in Type 2 diabetics, with over one quarter (27.7%) of those over 60's having previously undiagnosed HF in one report. Therefore it is one, if not the, most important assessment to be measured for all Type 2 diabetic patients and people with 2 or more comorbidities.

The Framingham Study found that individuals with asymptomatic left ventricular systolic dysfunction (LVSD) at entry had a nearly 5X increase in the risk of developing symptomatic heart failure (HF) compared to those with normal left ventricular function.

Kannel WB, Gordon T, and National Heart Institute (U.S.) (1968) The Framingham study: An epidemiological investigation of cardiovascular disease. Bethesda, MD., United States. Department of Health, Education, and Welfare, National Institutes of Health.

Heart disease may go undiagnosed until symptoms of myocardial infarction, heart failure, or arrhythmia appear. The goal should be to prevent heart failure symptoms by screening at-risk patients for asymptomatic heart dysfunction and implementing cost-effective interventions in the early stages. Echo is the most common way to diagnose heart failure, but our CardioANS can provide an inexpensive early screening for all at-risk patients with a high reimbursement. Also, the cardiorenal axis is a new target for intervention in heart failure. Cardiorenal and metabolic comorbidities are common in most people with diabetes and obesity and the interdependent relationship between the heart and the kidneys is an increasingly important target for intervention in the treatment of heart failure, as addressing both organs together can lead to better outcomes for patients.

Our CardioANS test is used by healthcare providers to evaluate their patient's risk of mortality and major adverse cardiovascular events (MACE). The CardioANS graphs the heartbeat as it moves through systolic and diastolic cycles. It tracks deviations in fingertip pressure caused by flexible arteries and produces a tight, regular graph for stiff arteries. Using a proprietary algorithm, the device analyses arterial pulse wave variations and compares them against a large body of research to accurately assess arterial hardening.

Cardiovascular disease causes 35% of female deaths worldwide.

IMPORTANT: Type 2 Patients on Metformin

Metformin remains the first-line therapy for type 2 diabetes, but emerging data—including a study published in the New England Journal of Medicine (NEJM)—has raised important questions about its impact on cardiovascular risk when used in certain populations or in combination with other agents.

While metformin has long been considered cardio-protective, recent evidence suggests that some patients—especially those with underlying autonomic dysfunction, subclinical heart disease, or multiple comorbidities—may face elevated cardiovascular risks that go unrecognized in early stages. This is where CardioANS™ becomes clinically essential.

CardioANS™: Detecting What the Eye Can’t See

CardioANS™ is a non-invasive autonomic function test that assesses sympathetic and parasympathetic balance, heart rate variability, and baroreceptor function—all of which are linked to cardiovascular risk and all-cause mortality. For patients with diabetes, particularly those on metformin, CardioANS™ provides an early physiologic signal of:

Cardiac autonomic neuropathy (CAN)
Silent myocardial stress
Decreased cardiovascular resilience

These are not always captured in routine bloodwork or physical exams.

Why It Matters Before an Echocardiogram

Echocardiograms provide valuable structural and functional imaging, but they don’t detect autonomic imbalance or real-time regulatory dysfunction. CardioANS™ helps fill that gap—identifying patients who may be:

At risk for arrhythmia or silent ischemia
Experiencing early signs of CAN, a major predictor of sudden cardiac death
Candidates for cardiology referral or further imaging

In this way, CardioANS™ can serve as a triage or validation tool before ordering echocardiograms, especially in asymptomatic patients where justification is needed for payers.

NEJM Reference Context

Studies published in NEJM (e.g., from the GRADE trial or post-hoc analyses) have indicated that cardiovascular outcomes with metformin are not uniformly beneficial, especially compared to newer agents like SGLT2 inhibitors and GLP-1 receptor agonists. This has prompted a more personalized risk-based approach to managing diabetes—and CardioANS™ provides exactly that.

Clinical Takeaway

For patients with diabetes on metformin:

CardioANS™ offers a quick, reimbursable, and non-invasive method to assess real-time cardiovascular risk
It can support decision-making before ordering more costly or invasive tests
It aligns with a preventive, risk-stratified care model increasingly favored by guidelines and payers

Before the Symptoms, Before the Echo—there’s CardioANS™.

Assessing Autonomic Balance and Stress Levels

Heart Rate Variability (HRV) is a critical metric that analyzes the variation in heartbeats to assess physical and mental stress levels as well as the balance of the autonomic nervous system (ANS). HRV measures the fluctuations in the time intervals between consecutive heartbeats, offering insights into the adaptability and health of the cardiovascular and autonomic systems. In healthy individuals, HRV demonstrates dynamic variability, indicating a flexible and responsive system. Conversely, individuals with compromised health often exhibit reduced variability, characterized by a steady and unchanging heart rate.

The autonomic nervous system consists of two primary branches: the sympathetic nervous system (SNS) and the parasympathetic nervous system (PNS). The SNS acts as the body's "accelerator," driving the fight-or-flight response during times of stress or danger, while the PNS serves as the "brake," promoting rest, recovery, and repair. Together, these systems maintain balance and regulate critical bodily functions such as heart rate, digestion, and respiratory patterns. A well-regulated autonomic nervous system is a hallmark of good health, allowing the body to adapt efficiently to various stressors and physiological demands.

The CardioANS device offers a non-invasive, reliable method to measure and monitor HRV, providing valuable insights into an individual's cardiovascular health and autonomic function. By analyzing HRV patterns, the CardioANS can identify imbalances or dysfunctions in the ANS that may contribute to stress, fatigue, or chronic health conditions. This data empowers healthcare providers to create personalized therapy protocols and recommendations tailored to the individual's unique needs.

CardioANS professionals are trained in interpreting HRV results and implementing targeted interventions to optimize cardiovascular and autonomic health. Whether used for early detection, ongoing monitoring, or preventive care, the CardioANS is a powerful tool for enhancing patient outcomes and promoting overall well-being. Through comprehensive analysis and individualized care, this advanced technology supports a proactive approach to health, helping patients achieve and maintain a balanced, resilient autonomic nervous system.

CVD & Long COVID-19

Post COVID-19 syndrome is a cluster of symptoms lasting many months after infection and may severely impacts a person for the rest of their life.

Long COVID-19 Consequences

COVID-19 can have implications for the cardiovascular system, particularly the left ventricle of the heart. Cardiomyopathy in COVID-19 patients refers to a condition where the heart muscle becomes inflamed and weakened due to the viral infection. Many people who have recovered from COVID-19 have reported experiencing lingering cardiovascular symptoms such as abnormal heartbeats, dizziness, and shortness of breath.

It's essential for individuals with long COVID, particularly those with cardiovascular symptoms, to be tested in the primary care setting to determine if there is should be more comprehensive imaging studies like echocardiograms to evaluate the structure and function of the left ventricle. Monitoring the left ventricle's health is crucial for developing targeted interventions and treatment plans to address the lingering cardiovascular effects of the virus.

Features of the tests:

3-minute non-invasive assessment
Measures the overall cardiovascular risk factors (heart attack and stroke)
Measures the left ventricle ejection and contraction power
Measures mental stress, physical stress, and resistance to stress

COVID-19 survivors, regardless of infection severity, are more likely to develop cardiovascular conditions such as heart failure or coronary disease within 30 days post-infection.

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