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FDA Launches TEMPO: What Digital Health Innovators Need to Know Now
FDA’s new TEMPO pilot creates a flexible, real-world evidence pathway for digital health, SaMD, DTx, wearables, and AI-enabled devices—aligned with CMS’s ACCESS model. Learn how innovators can use enforcement discretion to deploy faster, collect RWD/RWE, and strengthen future FDA submissions.
FDA Cracks Down on Wearable Devices: Lessons from WHOOP and Dexcom Enforcement Actions
Recent FDA actions against WHOOP and Dexcom reveal how wearables and SaMD are being regulated more aggressively. Here’s what digital health founders must know.