Can New Devices be Approved from Single Arm Studies: Use of Real-World Data as an External Control Group or for Propensity Matching or Generating Objective Performance Criteria

<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>Consultant Fee/Honoraria/Speaker's Bureau - Corvia; Zoll; Edwards Lifesciences; Impulse Dynamics; Boston Scientific Corporation; Medtronic; BackBeat Medical / Orchestra Biomedical; Abiomed</li><li>Grant Support/Research Contract - Zoll; Ancora</li><li>Equity/Stock(s)/Options - AquaPass; Xenter; Orchestra Biomedical</li></ul>