isza - Slashdot User

Comment Certification (Score 1) 79

by isza on Friday February 26, 2016 @06:34PM (#51595143) Attached to: More Medical Devices Should Be Open Source, Like This ECG

The device is going to have a CE mark (and hopefully FDA too, later). CE costs 50k USD, and you don't need human trials for such a standard device (you don't need to retest the efficiency of an electrocardiograph that does exactly the same as all the other ones, you just need to show that it does the same indeed). The investor is going to pay for it, and the business model is making money on the services instead of the device.

Submission + - More medical devices should be open source, like this ECG (github.com)

Submitted by isza on Friday February 26, 2016 @01:06PM

isza writes: This is a follow-up to the slashdot story http://goo.gl/nID9OY about mobilECG, a 12-lead clinical-grade ECG being open sourced. We have not given up on our goal to get rid of the high profit margin and dishonest distribution practices of diagnostic ECGs, and make a certified open source version of this important diagnostic device. After many months of hard work, there is now a working prototype of a much more capable device than the first version, with its sources available on GitHub (https://github.com/xdever/MobilECG-II). MobilECG now has a Holter function, changeable lead-configurations and Bluetooth. Here's a video of the prototype working: https://www.youtube.com/watch?.... Web: http://mobilecg.hu./

Submission + - Open Source Clinical 12-lead ECG Supports Tablets Too (mobilecg.hu)

Submitted by isza on Sunday November 17, 2013 @10:09AM

isza writes: MobilECG is the probably the first open source clinical-grade electrocardiograph with simultaneous 12-lead recording and Android support. It has been designed to meet all the relevant medical standards (ISO 60601-1, etc.). Manufacturing cost @ 1000 pieces: ~$110.

I had worked at a medical device company designing clinical electrocardiographs for three years.

Fed up with the unreasonably high price, cumbersome design, and dishonest distribution practices of clinical ECG machines, I started working on a high-quality ECG that is different.

After a couple of failed attempts to get funding for the expensive certification process and completely running out of funds, I decided to publish everything under a license that allows others to finalize and manufacture it or reuse parts of it in other projects.

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