This can’t-miss program will provide updates and practical takeaways for CEOs, venture capitalists, regulatory professionals and in-house legal counsel in the industry.

Our keynote speaker is Dr. William Maisel, Vice President & Senior Medical Officer, Intuitive Surgical and Former Chief Medical Officer & Director, OPEQ at FDA’s CDRH. Dr. Maisel will share insider insights from both FDA and industry, offering guidance on navigating successful submissions, understanding FDA review processes and managing regulatory disagreements. His keynote will be followed by an interactive Q&A.

The event begins with breakfast and includes lunch. A networking reception will follow the presentations.

Agenda:

8 a.m.: Breakfast | Registration | Networking

8:30 a.m.: Welcome remarks

8:45 – 9:45 a.m.: Navigating 409A: A Guide for Medical Technology Companies

Speakers:
- Deborah Andrews, Counsel at Fox Rothschild
- Rachel Flaskey, Director at Chartwell Financial Advisory Inc.

9:45 – 10:45 a.m.: Unlocking Clinical Success: Insights from Industry Leaders, Best Practices, and Emerging Trends

Speakers:
- Michele Shepard, VP of Clinical Affairs at Francis Medical
- Robin Solinsky, VP of Technology & Innovation at Bright Research
- Kathryn Dehn, MedTech Partner at Fox Rothschild

10:40 – 11 a.m.: Morning Break

11 a.m. - Noon: Inside the Edison® Deal: A Fireside Chat on HistoSonics' $2.25B Leap Forward

Speakers:
- Mike Blue, President and CEO at HistoSonics Inc.
- Brett Hanson, Partner at Fox Rothschild

Noon – 1 p.m.: Lunch | Networking

1 – 2 p.m.: Keynote Speaker: Dr. William Maisel, Vice President & Senior Medical Officer, Intuitive Surgical and Former Chief Medical Officer & Director, OPEQ at FDA’s CDRH

Moderator: Mark DuVal, CEO at DuVal & Associates

2 - 3:20 p.m.: CEO Panel Survivor Stories

Speakers:
- Alyssa Huffman, Allumin8
- Arnon Chait, Cleveland Dx
- John Schorgl, Peytant Solutions
Moderator: Bryan Feldhaus, President of Legal-Regulatory and Compliance at DuVal & Associates

3:20 - 4 p.m.: Working with the FDA Today (featuring CEO panel and Dr. Bill Maisel)