An Open Letter from the CEO of SE.ai

To All FDA and CDRH Professionals,

As the medical device regulatory landscape shifts, I know that many of you at the FDA and CDRH are facing uncertain times. The news of job cuts is devastating, especially for those of you who have dedicated your careers to ensuring the safety and efficacy of life-changing medical innovations. I want you to know that SE.ai deeply respects your expertise, your experience, and your commitment to improving healthcare.

At SE.ai, we are remaking the medical device regulatory ecosystem with cutting-edge AI tools designed to make the approval process faster, more efficient, and ultimately more impactful. We are building a new, optimized framework for medical device approvals, and we are doing it with the input and insights of experts like you.

This is a unique moment in time: an opportunity to help shape a future where regulatory processes are as innovative as the devices they govern. We believe that together, we can rebuild this system, creating something more streamlined and responsive to the evolving needs of the medical industry.

If you have expertise in medical device approvals and reviews, and you’re looking for an opportunity to use your skills to create something truly transformative, I invite you to join us. At SE.ai, your voice will not just be heard, it will be vital in shaping the future of the medical device regulatory ecosystem.

Let’s work together to build something better, something smarter, and something that works for everyone.

Warm regards,

Wren Gregory

Co-Founder & CEO, SE.ai