Medical device maker BioCardia put out a press release on August 24, 2026, announcing that the FDA has confirmed the meeting minutes for its Helix Transendocardial Delivery Catheter, which support a follow-on De Novo pre-submission for approval. In everyday terms: the company previously sat down with the FDA, and the agency has now signed off on the written record of that discussion — effectively paving the way for BioCardia to make its formal De Novo submission, the regulatory pathway used for novel medical devices. Keep in mind this 8-K merely 'furnishes' the press release for public reference (it's not a formally filed document), and the excerpt doesn't include any further detail beyond that.
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