Summarized by Masters of Longevity from Longevity Technology.
BioCardia’s regulatory roadmap outlines pursuing Japanese market clearance and parallel U.S. device review; this article explains the company’s approval strategy and next steps.
Key Takeaways
- BioCardia targets Japanese approval for heart failure therapy by 2027 Longevity.Technology is growing fast; we are open to conversations with prospective partners and investors who share our vision.
- The confirmatory CardiAMP HF II study is actively enrolling at four U.S.
- Centers and the FDA Center for Biologics Evaluation and Research has indicated the study may support a Pre-Marketing Application.
