How MedTech Startups Are Navigating the FDA's Software Pathway

In episode 35 of The Digital Health Podcast, Lucas and Luna unpack the FDA's evolving framework for regulating software-as-a-medical-device (SaMD). They focus on the agency's 2025 guidance on AI/ML-enabled devices and how it affects startups like IDx and Caption Health. Lucas explains the 'predetermined change control plan'—a mechanism that lets algorithms update without full re-clearance. Luna questions whether this really accelerates innovation or just shifts risk. They also discuss the de novo pathway, the 510(k) exemption for low-risk tools, and why some digital health companies are choosing not to pursue FDA clearance at all. A concrete look at regulatory strategy for anyone building or investing in health software. #DigitalHealth #SaMD #FDA #SoftwareAsAMedicalDevice #AIinHealthcare #MedTech #RegulatoryStrategy #IDx #CaptionHealth #PredeterminedChangeControlPlan #510kClearance #DeNovoPathway #Business #Technology #HealthTech #FexingoBusiness #BusinessPodcast #DigitalTherapeutics Keep every episode free: buymeacoffee.com/fexingo