Smart ECG Sentry

 

Smart ECG Sentry™

 
 

Donate generously and help make the Smart ECG Sentry™ a reality.

 

What is the Smart ECG Sentry™ ?

The Smart ECG Sentry™ is an improved version of the Holter type monitor, but with built-in Artificial Intelligence. Conventional Holter monitors are wearable devices that can be worn by patients suspected of abnormal heart activity or ECG irregularities. They are prescribed by GPs or specialist medical practitioners and are meant to simply measure and record your heart’s activity, in the form of ECG signal data, over an extended period of time. Say, for example, a week. They are worn ‘on-the-go’ i.e. while going about your normal, everyday routine. After the data has been collected it is then downloaded (a process that can take some time) and analyzed by your doctor (usually by visual inspection) for the purpose of diagnosing any underlying irregularities in heart rhythm. If your doctor isn’t a specialist cardiologist he may have to send your ECG data for further analysis. The process can be very slow and it doesn’t offer real-time, preemptive protection to the patient during the data collection phase.

In other words a Holter monitor is a wearable ECG recording device where the analysis is performed post hoc. This represents an obvious danger with previously undiagnosed,  serious heart conditions. The patient could suffer a catastrophic episode before the doctor has had a chance to look at the data. What is needed to mitigate this situation is a monitor that can catch and identify ectopic ECG signals ad lib, or in real time.

The Smart ECG Sentry™

The solution?  The Smart ECG Sentry™ is designed to be worn just like a conventional Holter monitor but, unlike a conventional Holter monitor, it is designed to analyze a patient’s ECG signal continuously, and in real time.  It uses Artificial Intelligence and Machine Learning algorithms in order to capture and identify abnormal or potentially serious heart activity, ‘on-the-go’.  In an emergency the Smart ECG Sentry™ will sound out an audible alarm  to the patient. Additionally, if the patient is unresponsive it will automatically notify emergency health care professionals, for immediate attention, by sending an electronic message or SMS, through the 4G cellular network . The Smart ECG Sentry™ not only records your ECG data, for later analysis and diagnosis, but it can also immediately notify both the patient and emergency health care workers during an emergency.

The Smart ECG Sentry™ is currently mid-way through its development cycle.  We estimate that 20% of the funds raised through donations will be allocated toward clinical testing and meeting local and overseas regulatory standards such as C.E. mark, TGA & FDA approval etc. 40% will be allocated to preproduction and manufacturing readiness. While the remaining 40% will be allocated to field trials. Our efforts together with your commitment and donations will help to bring the Smart ECG Sentry™ successfully to Australian and global communities.

What are the Potential Risks and Liabilities?

While it is still early days for the full legal ramifications of the use of AI in medical devices to be fully understood, world governments are doing their best to facilitate the safe¹ development of ‘smart medicine’ and to expedite its adoption.

Fortunately,  one factor which we consider helps to mitigate the risk involved is that, for devices such as the Smart ECG Sentry™,  conventional Holter monitors represent an even greater risk (being passive, non-preemptive devices), making them a less attractive proposition than devices powered by AI.

Project Phase Statement (State of progress toward a minimally viable product)

Phase 1 – 1st generation clinical data collection, 10%
Phase 2 – 1st generation software/hardware prototype system, 70%
Phase 3 – Integrated capability demonstration, 20%

 
 

Donate generously and help make the Smart ECG Sentry™ a reality.

 

References:

¹ https://www.expertinstitute.com/resources/insights/ai-medical-device-makers-still-protected-by-preemption-but-for-how-long/