Can we solve evidence and trust challenges in AI Medical Devices with Open Source?
The Northern European countries gathered last week for Estonian Health Tech Week, and Prof. Toralf Kirsten and Dr. Daniel Steinbach were invited to present their new concept of “For-Evidence Medical Devices.”
A recently published study on AI medical devices in radiology shows that 99% provide no evidence of patient outcomes. Once again, this confirms what we’ve been saying for a long time: we need much more clinical evidence when it comes to AI in medicine! --> https://doi.org/10.1007/s00330-025-11830-8
To close this gap, we must take a different approach than before. Our AMPEL solution: the development of an in-house medical device, designed with one priority above all else—the generation of new clinical evidence.
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