Breakthrough Device Designation & Its Impact on Reimbursement

What you need to know today, tomorrow, and how to prepare for the uncertain future.

Join for a practical discussion on the benefits and risks associated with FDA Breakthrough Designation and what it means for reimbursement, FDA interactions and time to market. What should I know about FDA Breakthrough Device designation so that I can speak intelligently to my team, investors, and customers?

Specifically, this webinar will cover:

• Overview of the upcoming breakthrough device designation changes

• Update on the number of devices that have Breakthrough Designation, what that means for your company’s regulatory journey, and strategies to leverage the program

• Benefits on Medicare reimbursement for devices with Breakthrough Designation

• Potential impact Breakthrough Designation on Medicare coverage and discussion on recent changes to the Medicare Coverage of Innovative Technologies (MCIT) rule

• The future for breakthrough devices

Who should attend?

• Medical Device Executives

• Regulatory Affairs Professionals and Management

• Reimbursement Professionals