The CardioSignal Telehealth Plan For Healthcare Professionals

CardioSignal is probably the easiest way to provide medical-grade atrial fibrillation detection to your patients and physicians wherever they are. The only device needed is a modern smartphone with an internet connection.

As atrial fibrillation is often asymptomatic or paroxysmal, having access to an instant detection capability will greatly improve the accuracy and speed to treat patients. CardioSignal can be applied to both screenings of large populations as well as tracking the exact condition of individual patients.

How does CardioSignal work?

CardioSignal uses the sensitive smartphone movement sensors, namely the accelerometer and the gyroscope, to detect variations in the human chest vibrations and micro-movements. Movements, that are caused by the physical motion of the human heart. The patient just needs to lay down, place the smartphone on their chest, and perform a 60 seconds measurement.

The CardioSignal solution consists of two parts:

  1. The CardioSignal mobile app, that gathers the movement sensor data on the phone. Available for both iOS and Android.
  2. The CardioSignal medical cloud, that analyzes the sensor data and gives the result instantly if atrial fibrillation was detected or not.

CardioSignal is a patented and clinically proven CE IIa-class medical device for detecting Atrial Fibrillation with 95.3% sensitivity and 96.0% specificity.

CardioSignal is committed to high measurement quality. When atrial fibrillation is detected the patient is asked to repeat the measurement. Confirming the finding with two consecutive detections. In addition, CardioSignal includes a built-in data quality assessment to check that the data is sufficient for proper analysis to efficiently minimize the number of false alarms.

CardioSignal is currently available in Europe and the US FDA approval is expected in mid-2021.

Where does CardioSignal fit in the care path?

An ECG confirmation by a physician is always needed to diagnose atrial fibrillation. CardioSignal is not meant to supersede this.

However, CardioSignal is meant to assist in finding the right patients at the right time for the ECG confirmation, which leads to a diagnosis and to the normal care path decided by the treating physician. Afterward, CardioSignal can again assist in understanding how the patient’s condition develops. 

What can you expect from CardioSignal?

Healthcare Providers

  • To be able to offer better and modern care.
  • Improved efficiency – digital services partially replacing regular visits, especially during COVID19 pandemic.
  • Decreasing the risk of employee sick leaves for corporate customers.
  • Optimal funneling of cardiology services: examinations to determine the etiology of atrial fibrillation, e.g. echocardiography.
  • Medical device distribution to patients is software-only, no need to manage physical devices.

 

Healthcare professionals

  • Find the right patient at the right time to be diagnosed and treated for atrial fibrillation.
  • Can ask the patient to do the measurement at home.
  • Can do the measurement on the patient themselves when ECG isn’t immediately available.

 

Patients

  • Can monitor themselves at home.
  • Can share the results with their physician*.
  • Enjoys an enhanced healthcare service.
  • Peace of mind.
  • No need to acquire physical measurement devices.

 

* Available in Q2/2021

From what we can see from our existing users is that when CardioSignal is given to a so-called optimal audience approx. 8% of all sought medical assistance after atrial fibrillation was detected. As the nature of atrial fibrillation is paroxysmal, the confirmatory ECG and diagnosis need to occur when the arrhythmia is still on. This was the case in over 50% of the individuals and the diagnosis was confirmed by their physician.

To put this example in perspective, in a group of 10 000 patients that match the optimal audience 800 patients will seek medical assistance because atrial fibrillation is detected by CardioSignal and 500 patients will receive an ECG confirmation.

The so-called optimal audience, i.e. user group, in our example consisted of individuals who have elevated risk to develop atrial fibrillation and thus a higher risk for stroke. The typical risk factors are assessed with CHA2DS2-VASc risk score. In our existing users the optimal audience can be described as follows:

  • Interest in personal heart health and willingness to perform self-measurements with a smartphone
  • Average age 58, ranging from 35 to 75.
  • Average body weight index: 27 (overweight)
  • Average CHA2DS2-VASc risk score: 1 (moderate risk)

 

How can you add CardioSignal into your portfolio?

The CardioSignal Telehealth Plan has two options: 1) the lightweight and easy to set up patient sign-up model, and 2) the fully integrated white-label model.

Option 1: The patient sign-up model

  • A dedicated web page for the patient sign-up is created on cardiosignal.com. Together we agree on what content the page has and how your patients are informed.
  • All patient communications happen within your communication channels. Patients are asked to visit the page and sign-up.
  • Patients receive automated emails to complete the sign-up and start using CardioSignal.
  • The CardioSignal product support is provided by us.
  • You receive regular progress reports.

This model requires no technical integrations whatsoever, is very fast to set up and lightweight to manage. All the heavy lifting is on our side. The only thing to agree on is the patient communication details. This model is also ideal for short and isolated pilots to try out the co-operation with CardioSignal.

Option 2: The white-label model

  • The CardioSignal capabilities are integrated directly into your mobile app. Your development team implements the user experience into your products.
  • We provide an integration library for your development team. This library handles the data gathering from the phone sensors and the connection to the CardioSignal medical cloud.

This model enables you to provide a seamless patient experience and integrate the atrial fibrillation detection capability into your healthcare processes however you wish. Also, this model can be applied to other devices than smartphones if they have the required sensors and internet connection.

Both options are available with an annual agreement, and pricing is based on the volume of user access rights you need. Enabling CardioSignal to be used for both small and large patient volumes. Annual agreements may be split for short pilot projects.

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