3 ms·
I think they would need FDA approval to even use a model since it would be considered a medical device correct?
by alexfromapex 7y ago
I think they would need FDA approval to even use a model since it would be considered a medical device correct?
- tedivm 7y agoIt depends on whether they have a radiologist review the results for accuracy or not. If they don't then it is a diagnostic tool, and would need approval. If it's just used to put higher priority patients in front of a radiologist sooner, and the radiologist does the diagnosing, then it might not need approval if they can show that the FDA has approved something similar in the past.