An open-source Holter ECG designed with KiCad


The prototype of our clinical standard open-source diagnostic holter/resting ECG (designed with KiCad) is finally working.



That looks great; has there been any work on certification for use on humans? The certification can be quite involved; since it operates on batteries you don’t have to worry about the possibility of accidental electrocution of the subject, but of course you need to protect the circuitry from defibrillators and electrocauterizers and it musn’t interfere with hearing aids, pace makers, or other possible medical equipment like insulin pumps.

A much smaller market (but easier to get certificates) is the Veterinary market. In Australia they happily pay AUD4000 for an animal ECG machine and the ones I’ve seen made in Australia are exceptionally bad - the programmers don’t seem to have any idea how to program embedded devices.

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Me and Robert ( have industrial experience in developing medical devices.

Of course we know about the 5kV test, the insulation requirements, maximum current, input impedance, EMI, etc. We are working on the hardware with those in mind.

We are planning to certify the device and get the CE (possibly FDA) mark, but as opposed to other manufacturers, we do not want to make a lot of money on manufacturing and selling it (it will be sold nearly at its cost).

Its main software will be open source too, so using the device in the traditional way will be free (apart from the cost of the device itself, of course).

For those who want to use it (or other devices) in more advanced ways (telemetry, home monitoring, etc.) we are developing commercial services.

That’s all good news - good luck and I hope the project is a great success. Some governments might even have grants to help provide such devices for developing nations and institutions like MSF might appreciate another organization donating some for them to test in the field. It’s good you already have experience qualifying medical devices. There might even be a suitable “crowdfunding” web site to help raise money for the certifications. I think it will help to have a product brief with specifications and brief description of the operation. For example, the power source, how long does it last, how does it interface with other devices so you can download the data, what type of electrodes does it use (I see from the video they are disposable types, but any particular brand of connector for the electrode), etc.