Amish Raval

New Capabilities

Presented late-breaking trial results at THT 2026

In March 2026, the FDA accepted BioCardia's pre-submission package for the Helix Transendocardial Delivery Catheter, the first catheter that injects cell and gene therapies directly into heart muscle, and scheduled a formal meeting for Q2 2026. The device, backed by fifteen clinical trials, uses a small helical needle anchored within the beating heart to precisely deliver therapeutic agents to damaged tissue; CDRH leads the review in consultation with CBER.

Updated May 27