Non-invasive cardiac diagnostic device for the non-invasive detection of up to 94% of all common heart diseases.
In Mexico, there is a high mortality rate from heart disease. We are talking about that, in 2017 there were about 141,619 people who died as a cause of heart disease and in 2018, 162,000. These numbers are dramatically increasing and concerning. In many cases the diagnosis is neither accurate nor conclusive resulting in a fatal outcome for the patient.
Therefore, the company Cardio Phoenix Inc. has developed a cardiac diagnostic device, non-invasive, powered by Artificial Intelligence whose main function, is the early detection of the onset of diseases and heart dysfunctions. Detects up to 94% of all common heart diseases, a higher percentage than the current State-of-the-Art devices.
The CHART device works by capturing novel heart bio-signals that when analyzed by CHART it provides objective assessment to the physician of the patient cardiac status.
All of this has been achieved through several years of research. Since 2011, CHART has been verified and validated in 3 large formal clinical studies, involving more than 3,900 patients and more than 10,000 tests. A consensus study involving the involvement of 16 Certified Cardiologists and numerous studies of repetition and reliability.
This device will bring great benefits because it will help primary care patients, and also all of those in rural areas by enabling Telemedicine. This means, CHART makes everybody equal. This technology will also provide the required medical justification to determine if the patient should be sent or not sent to the Cardiologist.
In addition, it has a high accuracy in diagnosis, capable of reducing FP and FN. With this, its efficiency increases by 250%. It is an easy-to-use medical device which greatly contributes in reducing downstream costs.
This device offers profitability by incorporating the latest technological innovations with a specific emphasis on reliability, simplicity and manufacturing, because the more affordable it is, the more accessible it is for all patients.
FDA cleared in June 2015, as K143432
Updated 510(k) in Dec 2018, as K182790
CHART Processing Algorithm in Process