BioCardia files revised FDA De Novo pre-submission for Helix catheter clearance
BCDA•BioCardia filed a revised FDA De Novo pre-submission for marketing clearance of its Helix catheter for heart agent delivery; the FDA targets an initial accept-or-refuse review within 15 days and written feedback or a meeting within 70 days.
1. FDA review timeline
BioCardia filed a revised De Novo pre-submission with the FDA for marketing clearance of its Helix catheter for heart agent delivery. The FDA previously raised no concerns about safety, performance or broad agent compatibility at a May meeting, whose minutes were accepted in August; it targets an initial accept-or-refuse review within 15 days and written feedback or a meeting within 70 days.
