Getting New EP Devices Approved: Evidence, Regulation, and Reimbursement

A brilliant prototype does not become a successful therapy by accident. This roundtable will follow the full journey from first concept to clinical adoption. Examining the evidence, regulatory strategy, trial design, reimbursement, and commercial decisions that determine whether a new EP device reaches patients. Experts will expose the common failure points, debate what “enough evidence” really means, and define how innovators can move faster without compromising safety or credibility.