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04/03/19 1:36 PM

#188082 RE: nidan7500 #188076

So all of the trials currently underway could be mining data to support ERP diagnostics...

Interesting.

The artificial intelligence technologies granted marketing authorization and cleared by the agency so far are generally called “locked” algorithms that don’t continually adapt or learn every time the algorithm is used. These locked algorithms are modified by the manufacturer at intervals, which includes “training” of the algorithm using new data, followed by manual verification and validation of the updated algorithm. But there’s a great deal of promise beyond locked algorithms that’s ripe for application in the health care space, and which requires careful oversight to ensure the benefits of these advanced technologies outweigh the risks to patients. These machine learning algorithms that continually evolve, often called “adaptive” or “continuously learning” algorithms, don’t need manual modification to incorporate learning or updates. Adaptive algorithms can learn from new user data presented to the algorithm through real-world use. For example, an algorithm that detects breast cancer lesions on mammograms could learn to improve the confidence with which it identifies lesions as cancerous or may learn to identify specific subtypes of breast cancer by continually learning from real-world use and feedback.



https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm635083.htm