Regulatory Landscape Exercise

Given what you learned throughout this lesson, but especially what we just learned about key stakeholders, we want you to get creative in this lesson and imagine a type of algorithm that you think would be clinically useful for 2D medical imaging, and what the FDA would think about it. This exercise is open-ended because there isn't really a right or wrong answer. What we want you to do is synthesize your current knowledge into a holistic idea about 2D imaging as it could be brought from bench to bedside.

Imagine an algorithm and cover the following elements in your solution:

• Disease or abnormality of interest
• What type of 2D imaging you will use
• What type of algorithm you would use (segmentation, localization, or classification)
• How your algorithm would fit into a medical imaging workflow
• How you think the FDA would classify your algorithm

We are going to cover all of these areas in more depth in Lessons 2, 3, and 4, so don't worry about having a correct answer. Be creative and see how deep your current understanding goes.

QUESTION:

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