BioCardia submits revised FDA pre-submission for Helix catheter

BioCardia, Inc. said on October 1, 2026 that it had finished a revised Pre-Submission to the FDA's Center for Devices and Radiological Health under the agency's Q-Submission program, seeking approval of its Helix Catheter for delivering therapeutic and diagnostic agents to the heart.¹

The filing follows an earlier round of FDA interaction. In May 2026, BioCardia and FDA met to go over the company's initial De Novo pre-submission.¹ According to the company, the agency indicated two possible routes to market clearance for Helix and did not flag concerns about the device's safety data, its performance, or its compatibility with general categories of therapeutic agents.¹ By August 2026, FDA had confirmed and accepted the meeting minutes as BioCardia had summarized them.¹ The company said its revised pre-submission reflects the guidance FDA laid out in those minutes.¹

BioCardia noted that if FDA clears Helix as the first device of its type, the company's clinical experience, drawn from 15 trials and covering close to 500 patients, could serve as a safety and performance benchmark that future similar catheters would need to match before winning their own clearance.¹

On timing, the company said FDA generally aims to decide whether to accept or refuse a submission for review within 15 calendar days, and to deliver written feedback or hold a meeting within 70 calendar days.¹

BioCardia also said a standalone clearance for Helix could widen its ability to work with developers of experimental cell, gene, and protein therapies that need targeted delivery to the heart.¹ The company described itself as a developer of cellular and cell-derived therapeutics for cardiovascular and pulmonary disease, based in Sunnyvale, California.¹