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The FDA just changed the game for medical innovation forever.
On December 1, 2025, Commissioner Marty Makary announced something unprecedented: agentic AI deployment across the entire FDA.
Not just chatbots. Not just automation.
We’re talking about AI systems that can plan, reason, and execute complex regulatory workflows autonomously.
Think about what this means:
• Pre-market device reviews that take weeks, not months
• Drug safety surveillance catching signals in real-time
• Biologics inspections streamlined through predictive analytics
• Meeting management that actually moves approvals forward
The numbers are staggering. Over 70% of FDA staff are already using Elsa, their LLM tool launched in May. Now they’re scaling to full agentic capabilities with human oversight built in.
💡 Here’s what healthcare innovators need to understand:
This isn’t about replacing human judgment. It’s about amplifying it. Every AI decision has human validation. Every workflow maintains regulatory rigor. But the speed? That’s where everything changes.
Imagine submitting your 510(k) and having AI agents immediately flag missing data, suggest comparable predicates, and route your submission to the right reviewers, all while you sleep.
Or picture post-market surveillance that catches adverse events patterns across millions of data points before they become crises.
The FDA even launched a two-month Agentic AI Challenge for staff to develop innovations. They’re not just adopting AI, they’re building a culture around it.
Makary said it best: “There has never been a better moment in agency history to modernize with tools that can radically improve our ability to accelerate more cures.”
For medical device companies, this means rethinking your regulatory strategy entirely. Your submissions need to be AI-ready: structured data, clear documentation, machine-readable formats.
For pharma, it means clinical trial data that speaks the language of algorithms, not just statisticians.
For digital health startups, this levels the playing field. AI doesn’t care if you’re a Fortune 500 or a Series A startup. Quality is quality.
The skeptics will worry about safety. Valid concern. But consider this: human reviewers miss patterns. They get fatigued. They have biases.
AI agents don’t. They just process, analyze, and flag, 24/7/365.
We’re witnessing the biggest shift in medical product regulation since the FDA was founded. The question isn’t whether to adapt, it’s how fast you can.
♻️ Repost if you believe AI will accelerate life-saving innovations to patients.
👉 Follow me, Jonathan Govette, for real-time updates on healthcare technology and business news. LinkedIn Profile: https://www.linkedin.com/in/jonathangovette/
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Author:
Jonathan Govette is a seasoned healthcare and technology executive with more than two decades of experience building, scaling, and advising digital health companies. He is the Co-Founder and CEO of Oatmeal Health, an AI-driven Lung Cancer Screening and Diagnostics company focused on expanding access to early detection for underrepresented populations, particularly patients served by Federally Qualified Health Centers and value-based health plans.
With a background in engineering, product development, and strategic partnerships, Jonathan has founded and led multiple health technology ventures across clinical care delivery, regulated medical software, and AI-enabled diagnostics. His work sits at the intersection of medicine, technology, and health equity, with a consistent focus on translating complex clinical problems into scalable, real-world solutions.
Jonathan has spent much of his professional life dedicated to improving outcomes for marginalized and underserved communities. He has designed and implemented frameworks that align clinical quality, reimbursement, and technology to sustainably advance health equity at scale. This mission is deeply personal and informs his leadership philosophy and long-term vision for healthcare transformation.
In addition to his operating experience, Jonathan is an author and long-time writer in the healthcare domain, with over 20 years of published work covering digital health, medical innovation, and healthcare systems. He is a frequent mentor to early-stage founders and regularly advises startups on product strategy, partnerships, and go-to-market execution in regulated healthcare environments.
Before entering industry full-time, Jonathan nearly pursued a career in medicine with an early path toward cardiothoracic surgery, an experience that continues to shape his clinical perspective and respect for frontline care delivery.
CEO | Oatmeal Health | AI Lung Cancer Startup | Engineer | Writer | Almost Became a Doctor (Cardiac Thoracic Surgeon) | 3x Health Tech Founder | Startup Mentor | Follow to share what I’ve learned along the way.
