BioCardia Confirms Timing and Provides Update on FDA Helix Pre-Submission and PMDA CardiAMP HF Shonin Submission
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BCDA• Regulatory submission timeline update
Sept. 23 (Reuters) - BioCardia Inc. BCDA.O:
- BioCardia confirms timing and provides update on FDA Helix pre-submission and PMDA CardiAMP HF Shonin submission.
- BioCardia said it plans to submit the Shonin pre-market application to PMDA in Q4 2026.
- The company said market clearance for CardiAMP in Japan could come by Q4 2027.
- BioCardia said it plans to submit the De Novo pre-submission for the Helix catheter system to the FDA this quarter.
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