FDA Clearance Announcement AI Innovations in Primary Care Heartcare

Toronto, Canada. On December 14th, Cardio-Phoenix Inc. received a 510 (k) clearance for its Cardio-TriTest™ v6.5 medical device from the U.S Food and Drug Administration (FDA). This is the second 510k the company has received, the first being issued June 3rd, 2015.

The Cardio-TriTest™ (CTT) device is a non-invasive medical device that collects 3 different types of heart bio-signals and combines them to create a more effective device able to detect and diagnose a much broader and wider range of common heart diseases than the state-of-the-art device, the ECG, currently used in Primary Care.

The CTT device is really 3-medical-devices-in-1. It includes a standard, hi-resolution, 12-Lead ECG device; plus, a 4 lead-Phonocardiograph (PCG) device; and, a 4 lead-Miraclecardiograph (MCG) device. The nature of the bio-signals characterizes the electrical, acoustical and physiological aspects of the heart, which are complementary and together provide a more complete diagnosis capability of cardiac status than is possible using ECG-only devices.
When paired with the Cardio-HART™, or "CHART" for short, a cloud based, AI based diagnostic and analysis system, also from Cardio-Phoenix, it can diagnose 94%, compared to ECG's 44%, of all common heart diseases, by prevalence, in Primary Care.

"By introducing AI into Primary Care, Cardio-Phoenix is poised to dramatically change the nature of heartcare in Primary Care. " —CEO

ECG only is no longer enough!

The ECG is the current state-of the art medical device widely in use in Primary Care today. However, little known to the public is that the ECG device has serious limitations – it can only detect a small range of common heart diseases, only ~44% . That's less than ½ of all common heart diseases. This makes it dangerous for use as a screening device in Primary Care.

Dangerous because many "sick" patients are unknowingly sent home - and forgotten! Dangerous because patients are led to believe they are "ok", when they might not be. Because they know of this limitation, that it can only detect 44% of all common heart diseases, many GP's and family physicians are very reluctant to prescribe this test to patients – precisely because ½ of all common diseases cannot be detected, which can lead patients into to a false sense of security.

Now compare that to CTT, with its three bio-signals, that can detect ~94% of all common heart diseases (by prevalence) at the Primary Care level, when part of the CHART system - 94%!

"94% vs 44% is a game changer!" —CEO

Compared to ECG, Cardio-TriTest™ has a far wider and much broader range of effectiveness, with higher sensitivity and specificity compared to ECG only based devices.

This makes it ideal for widespread patient screening in Primary Care – finally, a device GP's and family physicians can believe in that is cheap, easy, safe and highly effective.

"Such a device has long been needed and hoped for by the medical community, in particular by Family Practitioners. "
—Dr. Emese Uri, Dir. Of Ambulance (Primary Care)

Clinical Study Validated.

In a Validation Clinical Study of 1000 patients, that compared ECG to CTT , for diagnosing heart disease, and validated by Echocardiography, Cardio-TriTest (CTT) reduced False Negative (FN) rates by 24.2% and reduced False Positive (FP) rates by 6.7%.

The study revealed that 1 out of every 4 patients diagnosed by ECG was a FN – to be sent home with a "missed" or undiagnosed heart condition, whereas CTT properly detected/diagnosed them. The results were validated by Echocardiography.

Reducing FN means not sending sick patients' home, only to have them return via ambulance. It also leads to more timely disease detection leading to timely access to appropriate and cost-efficient treatment options. This represents a huge potential for savings, both to patients and to the health-care providers that must pay for them.

The study also indicated that compared to CTT, ECG diagnosed more FP, healthy patients sent for further testing that CTT indicated they didn't need, also validated by Echocardiography.

Reducing FP means fewer healthy patients filling the cardiologists waiting room, and not subjecting them to unnecessary and costly medical procedures, many invasive and of high-risk. At a time where many cardiologists are retiring, fewer are left to face an increasingly aging, and at-risk, population. The focus needs to be on treating "real" patients, not healthy patients.

"Each % reduction in the rate of FN and/or FP will result in much less suffering and will help realize significant system-wide cost-savings!"
—Dr. Tatjana Stankovic Chief of Cardiology

Intended for Primary Care.

The CTT device is intended to assist General Practitioners (GPs) in Primary Care to better understand the cardiac status of their patients. It is an aid to clinicians including family physicians, to help them better detect, identify and diagnose a much wider and broader range of common heart diseases and dysfunctions than is possible using the current state-of-the-art ECG devices. This will have a significant impact on Primary patient care, clinical productivity, healthcare costs and patient survival outcomes.

"Soon after CTT was introduced in the regional {Primary Care} clinics, we saw an immediate reduction in healthy patients in our cardiology clinic and realized they were coming with better referral details {medical justification}. As a result, we were able to better prioritize {triage} patients which helped reduce wait times…"
—Dr. Erzsebet Szabo, Cardiologist

"… after being told it {CTT} was intended mainly for use in Primary Care, I insisted on its use in clinical cardiology because it's a practical first-use device that allows us to quickly confirm referral diagnoses. It's also quite useful for detecting the presence of Ischemia…" —Dr. Aniko Bertini-Szabo, Chief of Cardiology

Effective, accessible and cost-efficient heartcare.

This newest version of the CTT device is a much-improved device incorporating the latest technological innovations with specific emphasis on reliability, simplicity and manufacturability – because the more affordable it is, the more accessible it is for all patients, not just the 1%.
"Being affordable and highly effective, CTT will finally allow for safe and effective widespread screening for heart disease in Primary Care that was not possible in the past with ECG devices. " —Dr. Emese Uri,
Dir. of Ambulance (Primary Care)

However, the biggest beneficial impact will be immediately and directly felt by those least able to afford advanced testing for heart disease. Diseases that were usually only diagnosed at the higher and most expensive levels of healthcare, will now, for the most part, be detected and diagnosed initially in Primary Care, obliterating the socio-economic glass-ceiling that prevented those least able to afford it, to justify and access the heartcare they need.

"Cardio-Phoenix's primary goal is effective heartcare, affordable and accessible, for all. "— CEO

3 years in the making.

Three years in the making, this version of the Cardio-TriTest v6.5 is greatly improved. The changes result from what was learned in 3 years of use in several large multi-site clinical studies that included thousands of patients, and 10's of thousands of examinations. The results include improved technology, producing better and less noisy signals, the innovative use of USB ports to simplify the use of the device and keep it affordable, an advanced EMI designs to ensure it works in noisy, signal filled medical environments, usability was also greatly enhanced, including a new harness design to make the placement of sensors on a patient easier, and more accurate. Even the color of the device was changed to a now benign, but friendlier, hospital beige. The user experience was updated to reduce, and for the most part eliminate, the potential for most human generated errors.

"As a trained ECG nurse, I required only a few of minutes of additional training to fully understand how to use it. Within minutes, I was conducting my first examination, followed by eleven more that day. I just cannot see how you can make a mistake with this system, it really is simple and understandable." —Valentina M, Nurse, Cardiology Ward

A Vision driven by a Relentless Commitment

Years in the making, this FDA 510(k) clearance further demonstrates that Cardio-Phoenix Inc., is no 1-trick pony. It is a clear example of the company's relentless commitment to implementing its vision of creating the most clinically effective and technologically innovative heart dysfunction detection and diagnostic solution, particularly for use in Primary Care.

"While we recognize the challenge of entering markets dominated by iconic devices dominated by large multinationals, our novel technologies will radically change the nature of heartcare, particularly in Primary Care…" —CEO

This incredible engineering and design team strived to create a truly next-generation AI enhanced heartcare technology for the detection and diagnosis of cardiac dysfunctions. This novel first-use technology is most effective when combined with the AI-driven CHART system and will be available as part of the CHART system. For further details, please visit us https://cardiophoenix.com/.

"In Primary Care, this is now the device of choice."
—The sentiment of every GP that has used it.

About the company
Cardio-Phoenix Inc.™ is a self-financed "startup", over a decade in the making, dedicated to the research and development of affordable, first-use, simple to use, non-invasive, AI based medical technologies for use in Patient Care Clinical Situations.

Our goal is to enable the early detection and diagnosis of the onset of the widest possible range of common heart diseases during normal patient screening, at the Primary Care level, where patients make the first contact with heartcare. Detection and diagnosis of 94% of all common heart diseases, by prevalence, is a good start.

For the GP, a better understanding of their patients cardiac status, to help them determine how to best help the patient.

For the cardiologist, a better patient, a medically-justified referral through collaborative triage.

For the healthcare system, reducing the costs, both human and financial.

For patients, better access to all, to affordable and effective heartcare, leading to a better quality of life. (and avoiding an ambulance ride).

Cardio-Phoenix Inc., a visionary innovator in a novel, AI & evidence-based medical innovation dedicated to better patient outcomes.
Bringing AI to Heartcare in Primary Care.