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All issues20 September 2026 · Full sample, free to read.

Six pulsed field ablation devices hold Class IV licences in Canada

Transcript

  1. 00:0035,744 licences on Health Canada's active listing.active-listing
  2. 00:02133 confirmed as electrophysiology devices.ep-confirmed
  3. 00:05Six pulsed field ablation devices hold Class IV licences in CanadaLicence 115505JSON
  4. 00:06Six pulsed field ablation devices hold Class IV licences in Canada. Five show status Issued/Conditional; the sixth, Affera (licence 115505), shows Issued/Active although its decision summary lists two conditions attached when it was issued.Licence 115505JSON
  5. 00:12The records, 22 July – 20 September 2026 · US and Canada · Issue 0: 51 FDA PMA decisions, 6 510(k) clearances, 1 Canadian EP licence.pma-decisions-window · 510k-window · ca-licences-window
  6. 00:19Six pulsed field ablation devices hold Class IV licences in Canada: 110572, PulseSelect Pulsed Field Ablation System; 111047, Farapulse Pulsed Field Ablation System; 111495, Varipulse Bi-directional Ablation Catheter; 115142, Volt PFA Catheter, Sensor Enabled; 115505, Affera Ablation System; 115863, Globe Pulsed Field System; 115141, Current PFA.Licence 110572JSON · Licence 111047JSON · Licence 111495JSON · Licence 115142JSON · Licence 115505JSON · Licence 115863JSON · Licence 115141JSON
  7. 00:25Know who’s entering your market™ ArrHub Alerts, arrhub.com

Each statement is tied to its evidence: a citation, a count from the records, or the check that tested it. A linked identifier opens the agency record.

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

Counts are as at 20 September 2026 unless a sentence gives another date.

Six pulsed field ablation devices hold Class IV licences in Canada

On 29 July, Health Canada licensed Kardium's Globe Pulsed Field System under licence 115863. It is a Class 4 device, and the register shows its status as Issued/Conditional, the code for a licence that carries conditions (MDALLJSON).

Conditional status is uncommon. Of the 35,744 active licences on the Canadian register, 124 carry it, or 0.35%. Yet five of the six Class IV licences that hold a pulsed field ablation catheter or system are conditional. The sixth, Medtronic's Affera Ablation System (115505), is listed as Issued/Active, although its decision summary attaches two conditions.

Of the 133 licences confirmed as arrhythmia electrophysiology devices, five are conditional: the four pulsed field licences in that set, and Abbott's Aveir leadless pacemaker (107649JSON). Abbott's Volt catheter is outside the confirmed set, because the keyword rule missed it at extraction.

The pulsed field ablation licences, as the register spells them:

LicenceSystemManufacturerClassStatusFirst licence status date
110572JSONPulseSelect Pulsed Field Ablation SystemMedtronic Inc.IVD, Issued/Conditional2023-12-13
111047JSONFarapulse Pulsed Field Ablation SystemBoston Scientific CorporationIVD, Issued/Conditional2024-04-04
111495JSONVaripulse Bi-directional Ablation CatheterBiosense Webster, Inc.IVD, Issued/Conditional2024-07-11
115142JSONVolt PFA Catheter, Sensor EnabledAbbott MedicalIVD, Issued/Conditional2026-04-01
115505JSONAffera Ablation SystemMedtronic Inc.IVI, Issued/Active2026-06-03
115863JSONGlobe Pulsed Field SystemKardium Inc.IVD, Issued/Conditional2026-07-29
115141JSONCurrent PFAAbbott MedicalIIII, Issued/Active2026-04-01

Abbott's Current PFA (licence 115141) is a generator system with no catheter. Its licence is active.

Corrected 22 September 2026: the headline previously read 'catheter and system'. Licence 115141 is a system with an active licence.

Corrected 24 September 2026: the headline and the finding previously read "Every pulsed field ablation catheter licensed in Canada is conditional" and counted five conditional Class IV licences with 115141 as "the sixth pulsed field licence". Licence 115505, Medtronic's Affera Ablation System, holds the Sphere-9 catheter, which its decision summary (RDS17111JSON) states delivers radiofrequency or pulsed field energy; it is Issued/Active, with two terms and conditions in the summary. The table gains its row. A search of licence names alone missed it.

Corrected 30 September 2026: two of the six Canadian licences cover the catheter only; 'systems' now reads 'devices'.

The name Current PFA (licence 115141) says neither catheter nor system. The FDA supplement record P250022/S005 calls it "Current PFA Generator", which places it as the generator for Abbott's Volt catheter. Both it and the TruPulse generator (111477), which drives the Varipulse system, hold active Class III licences.

The 43 other confirmed licences with "ablation" in their name are Issued/Active. One of them, the Affera Ablation System, delivers both pulsed field and radiofrequency energy, and its conditions appear in its decision summary rather than in its licence status.

Analysis. Six Class IV pulsed field ablation devices have been licensed in Canada in thirty-one months. So far, every one has carried conditions, either on its licence or in its decision summary.

Kardium's US file was active over the same months. Its approval, P240044, took three supplements between June and August; the most recent covers the Globe catheter's laminated ribs (FDA). The British Columbia company was licensed at home with conditions while it continued to amend its US approval. Neither agency's feed shows both.

Method note. Health Canada publishes licence status as a code. The licence register does not publish the conditions themselves; the Regulatory Decision Summaries print them for some licences (Documentary No. 01, Table 5). The terms used here are MDALL's own. This issue reports which licences carry the code and which decision summaries print conditions, and nothing beyond that.

Guidant remains on the Canadian register

Twenty years after the acquisition (8-K, April 2006), Guidant is still on Health Canada's register. Seven company records carry its name, with 77 licences under them. Every one of those licences is discontinued or cancelled, and no active electrophysiology licence sits under a Guidant name. A portfolio review that matches on company names will not find them.

Corrected 22 September 2026: this line previously read "MDALL still lists licences under Guidant Corporation and Guidant Advanced Cardiovascular Systems". The register carries seven Guidant company records with 77 licences under them, all discontinued or cancelled; no active licence sits under a Guidant name.

Corrected 25 September 2026: this paragraph previously ended "which is why the Boston Scientific figure in the cross-border section runs higher than the register alone would suggest". No record supports it: Boston Scientific's 24 confirmed licences sit under two Boston Scientific company records, and no Guidant company record contributes to the count.

Guidant is not the only case. In the records below, Farapulse resolves to Boston Scientific, Irvine Biomedical and St. Jude Medical to Abbott, and Medtronic CryoCath to Medtronic. Applicants are shown under the company that owns them where that link is documented, and each acquisition is cited to an SEC filing or the acquirer's release. Applicants not yet resolved are listed separately.

Corrected 27 September 2026: this paragraph previously read "Applicants below are resolved to the owning company". One applicant below, Swift Sync, Inc., is not yet resolved and is listed separately.

The records

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

Corrected 28 September 2026: four device names were printed cut off; they now appear as the register records them.

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 come from openFDA (the device/510k and device/pma endpoints) and link to the FDA record at accessdata.fda.gov. Canadian records come from Health Canada's Medical Devices Active Licence Listing (MDALL) API and link to the licence record on health-products.canada.ca; MDALL documents no web page per licence, so the API record serves as the citation. Fields are stored as the source names them, and records are checked against the source before publication, under the method published at arrhub.com/method. Applicants and licence holders are matched to organisations through an alias table: exact names by rule, division prefixes confirmed by a person, and acquisitions cited to an SEC filing or the acquirer's press release.

US coverage is the set of FDA product codes marked as relevant to electrophysiology in ArrHub's vocabulary. Three codes are left out on purpose: DQK (Computer, Diagnostic, Programmable), MHX (Monitor, Physiological, Patient, With Arrhythmia Detection Or Alarms) and MKJ (Automated External Defibrillators, Non-Wearable). Canadian coverage is the licences a person has confirmed as electrophysiology devices. Not yet covered: FDA recalls, MAUDE adverse events, and the EU's EUDAMED database (from December).

Links open the agency's own records. Unlabelled links open web pages. Links marked (JSON) open an agency's data record, which a browser shows as plain text. Links marked (PDF) open documents.

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About

ArrHub, at arrhub.com, keeps one identity per device, company and authorisation, built from primary regulatory sources. Alerts is its weekly edition. The EU layer opens in December.

I came to this from licensing. I am an intellectual property and technology lawyer with thirty years in patent licensing and technology law: codec pools at VoiceAge, and software and IP work for Cognos before IBM acquired it. Licensing runs on one rule, one identity per asset. A device cleared in three markets carries three unrelated numbers, and no register links them. So I built the crosswalk for one field.

The ArrHub Desk, Montreal and Toronto

Revised for style on 27 September 2026. No figure, identifier or finding changed. One sentence about applicants was corrected, as noted above.

Revised 1 October 2026: a line under the window states the date the counts are as at. No figure, identifier or finding changed.

Sources: openFDA and Health Canada's MDALL, and nothing else: no press releases, no secondary feeds, and no machine-written text in the records. The method is set out above. Resolution rules and acquisition citations are 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.