FDA and CMS just launched two new programs — RAPID and TEMPO — to help innovative medical devices reach patients faster. For startups, this could mean shorter gaps between FDA approval and Medicare coverage, or better ways to build real-world evidence. The catch? These programs only work if you understand them early and plan accordingly….
The regulatory environment for medical devices is becoming more constrained, and that is starting to affect how medtech startups interact with FDA. As workloads continue to rise inside CDRH, the practical result for sponsors is not just slower response times — it is a shift in the nature of engagement itself. More questions are being…
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….