BSX · Earnings call · 2026Q3T · Full report

Ultra Product Verification Delay

BOSTON SCIENTIFIC CORP · 2026-10-28 · Importance 7 · Surprise 24

Ultra is a PMA supplement that does not require a clinical study. Management attributed the one-quarter delay to design verification and validation work across the hardware, software, and catheter project. It said the delay does not involve a clinical trial or a need for clinical data to obtain approval.

Key facts

• Boston Scientific said Ultra is a PMA supplement that does not require a clinical study or clinical data for approval.
• Boston Scientific said Ultra involves hardware, software, and catheter work, and its delay was one quarter due to design verification and validation issues.