The Path Most Traveled: An Overview of the Breakthrough Device Designation — Can It Be Improved?

<p>Within the prior 24 months, I have had a financial relationship with a company producing, marketing, selling, re-selling, or distributing healthcare products used by or on patients: </p><ul><li>Grant Support/Research Contract - Volumetrix</li><li>Consultant Fee/Honoraria/Speaker’s Bureau - Alleviant Medical; CVRx; Edwards Lifesciences; Impluse Dynamics; V-Wave; Abiomed; Boston Scientific Corporation; Cardiac Dimensions; Merck/Schering Plough; Kestra</li></ul>