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THE TAPE

BlueWind gets a Category I CPT code for subfascial tibial neuromodulation Emboline runs its first US commercial Emboliner cases at Columbia SedMed raises $4M for a toilet lift that runs without power Surmodics buys Alta Biomed for its PzF coating and a Carlsbad blood loop lab FDA names the first five companies in its READI-Home readmissions program CDRH plans 11 final guidances in FY2027 and puts AI lifecycle management first Edwards wins FDA approval for a pulmonary valve that expands from 13 mm to 22 mm Medtronic wins a Category I CPT code for renal denervation, effective January 2028 Axogen closes the BioCircuit deal and puts $34M of 2027 revenue on NerveTape BlueWind gets a Category I CPT code for subfascial tibial neuromodulation Emboline runs its first US commercial Emboliner cases at Columbia SedMed raises $4M for a toilet lift that runs without power Surmodics buys Alta Biomed for its PzF coating and a Carlsbad blood loop lab FDA names the first five companies in its READI-Home readmissions program CDRH plans 11 final guidances in FY2027 and puts AI lifecycle management first Edwards wins FDA approval for a pulmonary valve that expands from 13 mm to 22 mm Medtronic wins a Category I CPT code for renal denervation, effective January 2028 Axogen closes the BioCircuit deal and puts $34M of 2027 revenue on NerveTape

Pre-Sub

BioCardia refiles a De Novo pre-submission for a catheter it has run through 15 trials

MedDevice Startups Staff · 4 days ago · 2 min read · Via BioCardia press release

BioCardia filed a revised De Novo pre-submission for its Helix catheter on October 1, going back to CDRH through the Q-Submission program. Helix delivers therapeutic and diagnostic agents directly into heart muscle. BioCardia says 15 clinical trials and nearly 500 patients sit behind it.

FDA met the company in May and agreed two pathways to marketing clearance exist, raising no concerns about Helix safety data, device performance or compatibility with general classes of agents. BioCardia folded that feedback into a revised filing in August. FDA has 15 calendar days to accept or refuse the submission and 70 calendar days to send written feedback or book a meeting.

A standalone clearance would make Helix sellable to cell, gene and protein therapy developers who need cardiac delivery and have no interest in running their own device program. That is the reason to separate the catheter from the therapy, and it is why the pathway question matters more here than the clearance date does.

Questions & Answers

What did BioCardia file with the FDA for the Helix catheter?

BioCardia filed a revised De Novo pre-submission for the Helix catheter on October 1, 2026, through FDA's Q-Submission program. Helix delivers therapeutic and diagnostic agents directly to the heart.

What did FDA tell BioCardia about the Helix catheter clearance pathway?

At a May 2026 meeting, FDA agreed that two pathways exist for Helix marketing clearance and raised no concerns about the device's safety data, performance or compatibility with general classes of agents. BioCardia incorporated that feedback into a revised submission in August 2026.

How long does FDA take to respond to a Q-Submission pre-submission?

For BioCardia's Helix filing, FDA targets an acceptance or refusal decision within 15 calendar days and written feedback or a scheduled meeting within 70 calendar days.

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