What changed, and when

Medtronic announced on 03 Feb 2026 that it will exercise its option to acquire CathWorks, valuing the deal at up to about $585 million with potential earn-outs and targeting close by the end of its fiscal 2026, subject to U.S. antitrust clearance (Company press release, Reuters).

60-second thesis frame

This is a workflow, evidence, and reimbursement bet. FFRangio, CathWorks’ angiography-derived, wire-free physiology software, has U.S. 510(k) clearance and is already commercial in the U.S., EU, and Japan, which supports adoption in labs that avoid pressure wires and adenosine (FDA 510(k) summary, Company press release). Reimbursement is the swing factor, since Category I CPT 75580 now covers CT-derived FFR, not angio-derived tools, keeping many angio solutions in Category III or local coverage, a headwind until broader payer alignment emerges (Diagnostic Imaging on CPT 75580, CMS local coverage article index). Competitive signal quality is improving but mixed versus wire-based physiology and QFR alternatives, so real-world outcomes and coding traction will drive confidence more than algorithms alone (European Heart Journal – Acute CVD comparison of FFRangio vs QFR).

The seven diligence questions

Clinical

• What is the reproducibility and diagnostic agreement of FFRangio versus invasive FFR across lesion types, left main, and ACS, and how does that compare head-to-head with QFR and vFFR in recent studies? (Head-to-head FFRangio vs QFR)
• Do ongoing or recently completed registries and trials provide outcomes evidence, not just diagnostic accuracy, for deferral and PCI guidance decisions? (ClinicalTrials.gov FAST-FFR)

Payer or Access

• What coding path will hospitals use in 2026 for angiography-derived FFR, given Category I CPT 75580 is specific to CT-derived FFR, and how do MACs treat Category III submissions for angio-derived tools? (Diagnostic Imaging on CPT 75580, CMS local coverage article index).
• Are large U.S. payers or IDNs publishing policies that would enable separate payment or favorable bundling for angio-derived physiology in cath lab workflows? (UnitedHealthcare summary of FFR policies)

Ops or Adoption

• Does FFRangio integrate with dominant hemodynamic and imaging consoles, and what is the median time-to-result in real-world labs versus wired FFR plus adenosine protocols? (FDA Access Data)

Competitive

• How does FFRangio’s performance and workflow compare to Medis QFR and Pie Medical CAAS vFFR, and what do recent ACS and real-world studies imply about deferral safety, revascularization rates, and downstream MACE? (J Cardiovasc Pharmacol Ther, FFRangio vs QFR, TCTMD on QFR deferral risk)

Team or Cap table

• What value-creation plan does Medtronic have for cross-selling FFRangio with its interventional portfolio, and how quickly can the deal pass Hart-Scott-Rodino review to enable integrated commercial execution by the April fiscal year-end? (Company press release, Reuters)

Red flags

• Antitrust delay or a second request would push closing beyond Medtronic’s fiscal 2026 guide and stall field integration. (Reuters note on FTC review, Reuters)
• If emerging head-to-head or outcomes analyses show inferior deferral safety versus wire-based FFR, adoption could stall even with strong workflow. (TCTMD report of higher events when deferring by QFR vs FFR, tctmd.com)
• Failure to secure consistent coding or local coverage for angio-derived FFR would keep economics unfavorable compared to CT-FFR’s Category I path. (CMS local coverage article index, Diagnostic Imaging on CPT 75580, Centers for Medicare & Medicaid Services)

Next catalyst

HSR filing and waiting-period outcome, with management targeting deal close by end of fiscal 2026, and any integration or coding updates on upcoming investor communications or FDA filings. (Company press release, Reuters)

FAQ

• What exactly changed by Medtronic’s “intent to acquire CathWorks” news on 03 Feb 2026, and why does it matter for coronary physiology adoption?
  Medtronic moved from a 2022 optioned co-promotion to a definitive intent to buy CathWorks for up to about $585 million, aiming to scale wire-free physiology in the cath lab to simplify PCI decisioning (Company press release, Reuters).
• What is the regulatory status today and in which markets is FFRangio available?
  FFRangio holds U.S. 510(k) clearance and is commercially available in the U.S., EU, and Japan per the companies’ disclosures (FDA 510(k) summary, 2022 Medtronic–CathWorks agreement).
• How is reimbursement evolving after Medtronic’s 03 Feb 2026 announcement, and does CT-FFR progress help?
  The AMA created Category I CPT 75580 for CT-derived FFR effective 2024, improving payment predictability for CT solutions, while angio-derived tools often rely on Category III coding or local policies, which can be inconsistent (Diagnostic Imaging on CPT 75580, CMS local coverage article index).
• Which endpoints in CathWorks’ clinical program drove the result, and how meaningful was the effect size?
  Validation was driven by studies showing a 93% diagnostic accuracy and 94% specificity when comparing the FFRangio System to invasive wire-based FFR (Cardiovascular Business). The system’s ability to provide a comprehensive assessment of the entire coronary tree from a standard X-ray was the primary clinical differentiator (Fierce Biotech).
• What safety issues matter post-acquisition, and do they change real-world use?
  The primary safety benefit is the elimination of hyperemic drugs like adenosine, which can cause patient discomfort or adverse reactions (Cardiovascular Business). However, the FDA notes that results must be used by clinicians in conjunction with other diagnostic tests to ensure AI-derived measurements do not lead to inappropriate treatment (FDA 510(k) Summary).

Publisher / Disclosure

Publisher: LucidQuest Ventures Ltd. Produced: 04 Feb 2026, London. Purpose: general and impersonal information. Not investment research or advice, no offer or solicitation, no suitability assessment. UK: directed at investment professionals under Article 19(5) and certain high-net-worth entities under Article 49(2)(a)–(d) of the Financial Promotion Order 2005. Others should not act on this. Sources and accuracy: public sources believed reliable, provided “as is,” may change without notice. No duty to update. Past performance is not reliable. Forward-looking statements carry risks. Methodology: questions-first framework using public sources. No conflicts. Authors do not hold positions unless stated. © 2026 LucidQuest Ventures Ltd.

Entities / Keywords

Medtronic; CathWorks; FFRangio; coronary physiology; PCI; ACS; invasive FFR; QFR; CAAS vFFR; wire-free physiology; 510(k); U.S. Food and Drug Administration; Federal Trade Commission; American Medical Association; Centers for Medicare & Medicaid Services; Category III CPT; CPT 75580; ClinicalTrials.gov NCT03226262; TCT; EuroPCR; HeartFlow; Medis Medical Imaging; Pie Medical Imaging; US; EU; Japan.

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