Looking for solid examples of open medical hardware

General
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Hi All,
Is anyone aware of open hardware that is considered a medical device and has gone through the FDA gauntlet to be approved and commercialized? The more examples the better - and exactly how they did it – e.g. using the approval process as a barrier to competition, etc.

Thanks - Joshua

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Hi Joshua

I’m aware of two examples:

The Glia stethoscope is manufactured in a facility approved by Health Canada, I don’t think to date they have FDA approval though:

https://trklou.medium.com/glia-stethoscope-2-0-fixing-problems-in-an-open-source-medical-device-d4938b84e84c

Mechanical Ventilator Milano was approved by the FDA but I’m not sure how 100% open it is

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8060010/

Jenny

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The Open Syringe Pump by Electrolab Nanterre.
It was actively used in French hospitals during the Covid-19 pandemic. I’m not sure if they have full certification, or if they used a lightweight process that was possible during that time.

Andreas

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The UK based OpenBionics prosthetic arm :mechanical_arm: started as opensource, won a Dyson award, grew commercially backed by Disney and has recently been approved by the NHS.

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Thanks Everyone - this is very helpful!

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