What is the FDA de novo pathway for digital health?

The archive doesn't contain a substantive explanation of the FDA de novo pathway itself. One episode mentions de novo approval in passing [#442], noting that an ultrasound-plus-AI diagnostic tool had received de novo clearance, but doesn't explain what the pathway is, how it works, or what distinguishes it from other FDA routes.

To answer this properly, I'd need episodes that discuss FDA pathways for digital health more systematically: how de novo differs from 510(k) clearance, what evidence is required, typical timelines, or founder experience navigating it. A sharper question might be: "What have founders said about their FDA approval process for digital health products?" or "How does FDA regulation work for digital therapeutics?"