All issues20 September 2026

ArrHub Alerts — Sample Issue

Window: 22 July – 20 September 2026 · US and Canada · Issue 0

Every pulsed field system in Canada is licensed conditionally

Kardium took Health Canada licence 115863 for the Globe Pulsed Field System on 29 July — Class 4, status Issued/Conditional (MDALL).

That status is worth a second look. Of 35,744 active licences on the Canadian register, 124 carry conditional status — 0.35%. Every Class IV licence for a pulsed field ablation catheter or system carries it: five of five. Of the 133 confirmed arrhythmia EP licences, five are conditional — the four pulsed field systems inside that set and Abbott's Aveir leadless pacemaker (107649); Abbott's Volt catheter sits outside the confirmed set because the keyword rule missed it at extraction. The register's pulsed field ablation licences, as it spells them:

LicenceSystemManufacturerClassStatusFirst licence status date
110572PulseSelect Pulsed Field Ablation SystemMedtronic Inc.IVD, Issued/Conditional2023-12-13
111047Farapulse Pulsed Field Ablation SystemBoston Scientific CorporationIVD, Issued/Conditional2024-04-04
111495Varipulse Bi-directional Ablation CatheterBiosense Webster, Inc.IVD, Issued/Conditional2024-07-11
115142Volt PFA Catheter, Sensor EnabledAbbott MedicalIVD, Issued/Conditional2026-04-01
115863Globe Pulsed Field SystemKardium Inc.IVD, Issued/Conditional2026-07-29
115141Current PFAAbbott MedicalIIII, Issued/Active2026-04-01

Licence 115141, Current PFA, is not a catheter or system by name; the FDA supplement record P250022/S005 names it "Current PFA Generator", which places it as the generator for Abbott's Volt catheter. It is the only one of the six that is not conditional.

No conventional RF or cryo system in the confirmed EP set holds conditional status: the 43 other confirmed licences with "ablation" in the name are all Issued/Active. Five entrants, thirty-one months, one posture from the regulator. Anyone modelling Canadian market access for a PFA platform should assume conditions apply and plan the post-market obligations accordingly.

Kardium's US file moved in the same stretch: P240044 took three supplements between June and August, the most recent for the Globe catheter's laminated ribs (FDA). A BC company licensed at home with conditions while iterating on its US approval — neither agency's feed shows both halves.

Method note. Health Canada publishes licence status as a code; the register does not publish the conditions themselves. What is stated above is which licences carry the code, nothing more. Terminology is taken from MDALL's own documentation.

Guidant remains on the Canadian register

Twenty years after Boston Scientific completed the acquisition (8-K, April 2006), MDALL still lists licences under Guidant Corporation and Guidant Advanced Cardiovascular Systems. A portfolio review that reconciles by company name will not find them — which is why the Boston Scientific figure in the cross-border section runs higher than the register alone would suggest.

The same applies elsewhere. Farapulse resolves to Boston Scientific, Irvine Biomedical and St. Jude Medical to Abbott, Medtronic CryoCath to Medtronic. Applicants below are resolved to the owning company; acquisitions are cited to an SEC filing or an acquirer release.

The records

US PMA decisions: 51 · US 510(k) clearances: 6 · Canadian EP licences issued: 1 · Organisations covered: 11

US — PMA originals and 180-day / panel-track supplements

Abbott

Boston Scientific

Johnson & Johnson

Medtronic

Stereotaxis

US — 30-day notices and real-time supplements

US — 510(k) clearances

Canada — EP licences first issued in window

Cross-border

Organisations with US events in window and Canadian EP licences

Organisations with US events in window and no Canadian EP licence

Applicants not yet resolved to an organisation

Sources and method

US records are read from openFDA (device/510k and device/pma endpoints) and link to the FDA record at accessdata.fda.gov. Canadian records are read from the Health Canada Medical Devices Active Licence Listing (MDALL) API and link to the licence record on health-products.canada.ca; MDALL documents no per-licence web page, so the API record is the citation. Every field is stored as the source names it and each row is verified against its source record before publication. Applicants and licence holders are resolved to organisations through a verified alias table (exact-name rule; division prefixes confirmed by a person; acquisitions cited to an SEC filing or acquirer press release). US scope is the set of FDA product codes flagged EP-relevant in the controlled vocabulary; excluded on purpose: DQK (Computer, Diagnostic, Programmable), MHX (Monitor, Physiological, Patient, With Arrhythmia Detection Or Alarms) and MKJ (Automated External Defibrillators, Non-Wearable). Canadian scope is licences a person has confirmed as EP. Not yet covered: FDA recalls, MAUDE adverse events, and EU EUDAMED (December).

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Each issue covers the week's regulatory events at device level across the US and Canada, resolved to the owning company, with every line linked to the agency record. Recalls and adverse-event signals follow. In the first week of December, the EU: EUDAMED's legacy-device registration deadline falls on 28 November, and the week after is the first point at which that database is complete enough to read. Founding subscribers receive it first.

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Errors and omissions: reply to this issue. Corrections are published.

About

ArrHub is a network for the arrhythmia device industry — one identity per device, company and authorization, built from primary regulatory sources and published across arrhub.com, arrhythmia.ca, arrhythmia.uk, arrhythmia.fr, arrhythmia.eu and the rest. Alerts is the weekly feed off it. The EU layer opens in December.

I came to this from licensing. Thirty years structuring patent deals — codec pools at VoiceAge, software and IP work for Cognos before IBM acquired it — and the constant across all of it is that nothing works until every asset has one identity everyone agrees on. Medical devices don't have that. A device cleared in three markets carries three unrelated numbers and no crosswalk between them. So I built the crosswalk for one field.

Bruno Deslauriers Dalimer Corporation, Toronto

Sources: openFDA and Health Canada MDALL. Nothing else — no press releases, no secondary feeds, no generated text in the records. Method is above. Resolution rules and acquisition citations available on request. ArrHub reports public register records; it does not assess patent scope, validity or infringement, and nothing here should be read as doing so.