Biocardia (BCDA) news

Europe's STOXX 600 pares gains after US CPI, last up 0.46%

European stocks trimmed gains on Thursday as investors digested the latest U.S. inflation data, which showed a 0.4% rise in consumer prices for January, bringing the annual rate to 7.2% . The pan-European STOXX 600 index had earlier risen 0.46% but pared those gains as traders weighed the…

Ocado sales up 12.4% in 12 weeks to October 4 year-on-year, says Worldpanel

BioCardia - FDA targets initial review within 15 days and feedback or meeting within 70 days

BioCardia, Inc. (NASDAQ: BCIA) has confirmed the timing of its pre-submission meeting with the U.S. Food and Drug Administration (FDA) regarding its Helix Cell Delivery System. According to the company, the FDA has indicated that its initial review of the submission is expected to occur within 15…

BioCardia - FDA raises no concerns regarding Helix safety data or device performance

BioCardia, Inc. (Nasdaq: BCDA) recently reported that the U.S. Food and Drug Administration (FDA) raised no concerns regarding the safety data or device performance of its Helix Transendocardial Delivery Catheter System during a Pre-Submission Meeting. The meeting, held in May 2026, outlined two…

BioCardia - To submit de novo pre-submission for Helix catheter system to FDA this quarter

BioCardia, Inc. (Nasdaq: BCDA) has completed its Pre-Submission to the U.S. Food and Drug Administration (FDA) under the Q-Submission program for its Helix Transendocardial Delivery Catheter system, a key component of the company’s cell and gene therapy delivery platform. The submission is part of…