FDA Clears the Runway for Wearables and AI: What Medtech Innovators Need to Know
The regulatory ground under wearable and AI-enabled devices is shifting—and for once, it’s in a direction many innovators will welcome. In early 2026, FDA issued updated guidance on low‑risk wellness products (including many wearables) and on clinical decision support (CDS) software, easing premarket requirements for certain functions while clarifying where full device regulation still applies….