RegulatoryCompany release

Boston Scientific cuts Q4 outlook after cyber incident as FDA clears new urology and peripheral devices

🇺🇸 Boston Scientific Corp (BSX) · Wed 28 Oct 2026

The company reported Q3 net sales of $5.138bn and lowered its fourth-quarter guidance to a 1% to 3% decline, while announcing FDA clearances and new CPT codes.

Boston Scientific reported third-quarter 2026 results on 28 October, with net sales of $5.138bn. The company said it now expects fourth-quarter sales to fall by 1% to 3%, lowering its outlook after a cybersecurity incident disrupted its operations.

On the regulatory side, the company received FDA 510(k) clearances during the quarter for urology tools within its StoneSmart ecosystem. It also gained clearance for an expanded SEISMIQ intravascular lithotripsy catheter, intended for peripheral artery disease.

In clinical development, Boston Scientific began enrolling patients in the Elite AF trial, which is studying its next-generation WATCHMAN Elite left atrial appendage closure device.

On reimbursement, the company noted that the American Medical Association has assigned Category I CPT codes for renal denervation and for implantable tibial nerve stimulation. Both codes take effect in January 2028.

The summary available does not give further detail on the cybersecurity incident, its scope or its effect on specific products or supply.

What it means for your team

  • Cybersecurity incidents can interrupt manufacturing and commercial operations; quality and supply teams may wish to review their own resilience and incident-reporting plans.
  • The 510(k) clearances for StoneSmart urology tools and the expanded SEISMIQ catheter widen the company's US device portfolio in urology and peripheral artery disease.
  • Category I CPT codes for renal denervation and implantable tibial nerve stimulation, effective January 2028, are relevant to US market-access and reimbursement planning.
  • The start of enrolment in the Elite AF trial signals continuing clinical evidence generation for next-generation WATCHMAN technology.

Company's press release (SEC filing): Boston Scientific Corp ↗

Article written by VigiEye from the official source (Boston Scientific Corp). Claims are the company's own. AI-assisted; check the source before acting.

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