President, Chief Executive Officer & Co-Founder, BioCardia
Appears in 1 story
Leading dual regulatory tracks for Helix catheter and CardiAMP therapy
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
No stories match your search
Try a different keyword
How would you like to describe your experience with the app today?
