CardiAMP Cell Therapy

2 articles
GlobeNewswire Inc.GlobeNewswire Inc.··Biocardia, Inc.

BioCardia Gets FDA Nod on Dual Pathways for Helix Catheter System

BioCardia secured FDA alignment on two regulatory routes for its Helix transendocardial delivery catheter, with the agency backing simultaneous approval with CardiAMP cell therapy.
BCDAcell therapymedical device
GlobeNewswire Inc.GlobeNewswire Inc.··Biocardia, Inc.

BioCardia's Helix Catheter Clears FDA Pre-Submission Milestone

BioCardia wins FDA acceptance of pre-submission package for Helix transendocardial delivery catheter, advancing minimally invasive cardiac therapy platform.
BCDAFDA approvalminimally invasive