FDA Hiring, AI Imaging & Ortho Innovation
This week on Trying to Keep Up, Allison Komiyama and Michael Nilo are joined by former FDA leader and regulatory consultant Melissa Hall to break down what’s actually happening inside FDA right now—and what it means for medtech companies trying to navigate it.
From a surge in CDRH hiring to delays in De Novo summaries, the team unpacks how regulatory realities are evolving in real time. They also dive into a surprising PMA approval for an AI-enabled breast imaging system and what it reveals about inconsistency in classification decisions.
Plus: a deep (and slightly gruesome) look at Lindsey Vonn’s injury and recovery highlights the real-world impact of orthopedic devices—from external fixation systems to plates, screws, and ligament reconstruction technologies that make modern recovery possible.
As always, the conversation blends practical regulatory insight with candid commentary—and a few terrible jokes.
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