- Posted August 5, 2026
- In AI, EU MDR, FDA, medical devices, regulation, SaMD
How Software Became a Medical Device
The Therac-25 reached the US market in 1983 by declaring itself equivalent to something already on sale. Forty years later, 97% of AI-enabled medical devices get there the same way. How the category was assembled backwards, one definitional crisis at a time.
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