Corrections
Chaque correction, de la plus récente à la plus ancienne : la date, la page, ce qui était écrit, ce qui est écrit maintenant, et pourquoi. Les corrections des lecteurs sont à envoyer à alerts@arrhub.com ; chacune reçoit une réponse, et la réponse est consignée, qu’un changement suive ou non.
Corrigé le 10 octobre 2026
a licence number now links to Health Canada’s licence page on MDALL, with the API record beside it, marked (JSON). No figure, identifier or finding changed.
Revised 10 October 2026: a licence number now links to Health Canada’s licence page on MDALL, with the API record beside it, marked (JSON). No figure, identifier or finding changed.
Tel qu’imprimé dans le numéro : Révisé le 10 octobre 2026 : un numéro d’homologation renvoie désormais à la page de l’homologation sur MDALL de Santé Canada, avec le dossier de l’API à côté, marqué (JSON). Aucun chiffre, identifiant ni constat n’a changé.
Corrigé le 10 octobre 2026
a licence number now links to Health Canada’s licence page on MDALL, with the API record beside it, marked (JSON). No figure, identifier or finding changed.
Revised 10 October 2026: a licence number now links to Health Canada’s licence page on MDALL, with the API record beside it, marked (JSON). No figure, identifier or finding changed.
Tel qu’imprimé dans le numéro : Révisé le 10 octobre 2026 : un numéro d’homologation renvoie désormais à la page de l’homologation sur MDALL de Santé Canada, avec le dossier de l’API à côté, marqué (JSON). Aucun chiffre, identifiant ni constat n’a changé.
Corrigé le 9 octobre 2026
PULSESELECT PULSED FIELD ABLATION SYSTEM, AFFERA ABLATION SYSTEM, AVEIR LEADLESS PACEMAKER, CURRENT PFA, TRUPULSE GENERATOR, as Health Canada records them.
Auparavant : Licence and device names printed in title case, for example PulseSelect Pulsed Field Ablation System, Affera Ablation System, Aveir leadless pacemaker, Current PFA, TruPulse generator.
Corrected 9 October 2026: licence and device names are now printed as Health Canada records them, including capitalisation. Register names and identifiers are printed as the register holds them, including case and punctuation (STYLE.md F11).
Tel qu’imprimé dans le numéro : Corrigé le 9 octobre 2026 : les noms d’homologations et d’instruments sont désormais imprimés tels que Santé Canada les consigne, y compris la casse.
Corrigé le 1er octobre 2026
a line under the window states the date the counts are as at. No figure, identifier or finding changed.
Revised 1 October 2026: a line under the window states the date the counts are as at. No figure, identifier or finding changed.
Tel qu’imprimé dans le numéro : Révisé le 1 octobre 2026 : une ligne sous la période indique la date à laquelle les décomptes sont établis. Aucun chiffre, identifiant ni constat n’a changé.
Corrigé le 30 septembre 2026
Six pulsed field ablation devices hold Class IV licences in Canada
Auparavant : Six pulsed field ablation systems hold Class IV licences in Canada
Corrected 30 September 2026: two of the six Canadian licences cover the catheter only; 'systems' now reads 'devices'. Licence 111495 is VARIPULSE BI-DIRECTIONAL ABLATION CATHETER and licence 115142 is VOLT PFA CATHETER, SENSOR ENABLED. Where a sentence counts licences rather than products, it now says 'licences'. In Documentary No. 01, one sentence was also removed because it read as advice to the reader (Revised 30 September 2026).
Tel qu’imprimé dans le numéro : Corrigé le 30 septembre 2026 : deux des six homologations canadiennes visent la sonde seule ; « systèmes » se lit désormais « instruments ».
ArrHub Alerts, 20 September 2026Documentary No. 01, HTML and PDF
Corrigé le 28 septembre 2026
Each such name is printed to its last complete word, followed by an ellipsis, its bracket closed, and "(truncated in the FDA record)". Eighteen names on this page carry the mark. No name was lengthened.
Auparavant : Four device names in The records were printed cut off, as the register's field holds them: the FARAPULSE row of 25 August ended "FARASTAR Catheter Connection Cable," with its bracket open, and the Abbott, Boston Scientific and Medtronic notice summaries held names ending in an orphaned comma or semicolon or an open bracket.
The FDA's PMA database holds its trade name field cut at 120 characters; openFDA and the PMA page on accessdata.fda.gov print the same cut value. ArrHub stores the field as the register gives it. The house style (STYLE.md, F6) has a device name printed complete or shortened at a word boundary with an ellipsis, never with an orphaned comma, semicolon or open bracket, so the cut is now marked instead of reproduced. A name is marked only when it is at the cap and ends mid-list or mid-word; a name at the cap that ends cleanly is printed as held. The mark names the FDA record, since the cap is shown on that field alone: 510(k) device names and Health Canada licence names are printed as held.
Tel qu’imprimé dans le numéro : Corrigé le 28 septembre 2026 : quatre noms d’instruments étaient imprimés tronqués ; ils figurent désormais tels que le registre les consigne.
Corrigé le 27 septembre 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.
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.
Tel qu’imprimé dans le numéro : Corrigé le 27 septembre 2026 : ce paragraphe disait auparavant « Les demandeurs ci-dessous sont rattachés à l’entreprise propriétaire ». Un demandeur ci-dessous, Swift Sync, Inc., n’est pas encore résolu et est présenté à part.
Corrigé le 27 septembre 2026
No figure, identifier or finding changed. One sentence about applicants was corrected, as noted above.
Revised for style on 27 September 2026. No figure, identifier or finding changed. One sentence about applicants was corrected, as noted above.
Tel qu’imprimé dans le numéro : Révisé pour le style le 27 septembre 2026. Aucun chiffre, identifiant ni constat n’a changé. Une phrase sur les demandeurs a été corrigée, comme indiqué plus haut.
Corrigé le 25 septembre 2026
A portfolio review that reconciles by company name will not find them.
Auparavant : 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 clause said that Guidant licences raise Boston Scientific's Canadian licence count. The cross-border count is of licences confirmed as EP under company records resolved to Boston Scientific: 24, under two Boston Scientific company records (139858 and 102065). The seven Guidant company records hold no confirmed EP licence and no active licence, so they add nothing to the figure. The clause was written without a record and is removed; a dated correction line stands in its place.
Tel qu’imprimé dans le numéro : Corrigé le 25 septembre 2026 : ce paragraphe se terminait auparavant par « ce qui explique que le chiffre de Boston Scientific dans la section transfrontalière soit plus élevé que ne le laisserait croire le seul registre ». Aucun dossier ne l’appuie : les 24 homologations confirmées de Boston Scientific se trouvent sous deux fiches d’entreprise Boston Scientific, et aucune fiche d’entreprise Guidant ne contribue au décompte.
Corrigé le 25 septembre 2026
ArrHub is published by Dalimer Outsourcing Inc., doing business as ArrHub.
Auparavant : The publisher line named the group's holding company, Toronto.
The publisher line previously named the group's holding company; ArrHub is published by Dalimer Outsourcing Inc., doing business as ArrHub. The footer now reads "© 2026 ArrHub. Content made available under licence."; the About paragraphs on arrhub.com, in Issue 0 and in Documentary No. 01 end "ArrHub is published in Montreal and Toronto."; the issue and document JSON-LD name ArrHub as publisher with its legal name; the supplier information page carries the contracting party. The documentary and supplier PDFs are re-rendered, and the documentary cover reads Revised 25 September 2026.
arrhub.comArrHub Alerts, 20 September 2026Documentary No. 01, HTML and PDFSupplier information, HTML and PDF
Corrigé le 24 septembre 2026
The headline previously said every pulsed field ablation catheter licensed in Canada is conditional. Licence 115505, a pulsed field system with status I, was missed because its licence name does not contain the words searched; its device list and decision summary do.
Auparavant : Every pulsed field ablation catheter licensed in Canada is conditional. Five Class IV pulsed field ablation licences on Health Canada's active listing carry status Issued/Conditional, and the sixth pulsed field licence, 115141, is a Class III generator system whose licence is active.
Licence 115505, Medtronic's Affera Ablation System (Class IV, Issued/Active, first licence status date 3 June 2026), holds the Sphere-9 catheter and the HexaPulse PF generator; its Regulatory Decision Summary RDS17111 states that the catheter delivers radiofrequency or pulsed field energy and attaches two terms and conditions. The licence name does not say pulsed field, and the search behind the headline covered licence names alone. The register's device names and the summaries' text are now searched as well, which also surfaced the TruPulse generator (111477, Class III, active), the generator of the Varipulse system. Table 1, Table 3, Table 4 and Table 5 of the documentary gain their rows; every claim that says every, all, none, only or an ordinal now carries an adversarial search object the gate runs before publication.
Tel qu’imprimé dans le numéro : Corrigé le 24 septembre 2026 : le titre et la conclusion disaient auparavant « Toutes les sondes d’ablation par champ pulsé homologuées au Canada sont conditionnelles » et comptaient cinq homologations conditionnelles de classe IV, avec 115141 comme « la sixième homologation de champ pulsé ». L’homologation 115505, l’AFFERA ABLATION SYSTEM de Medtronic, vise la sonde Sphere-9, dont le sommaire des décisions réglementaires (SDR) ([RDS17111](https://health-products.canada.ca/api/dhpr/controller/dhprController.ashx?linkID=RDS17111&pType=rdsmd&lang=en)) indique qu’elle délivre de l’énergie de radiofréquence ou de champ pulsé ; elle est Issued/Active, avec deux conditions au sommaire. Le tableau gagne sa ligne. Une recherche sur les seuls noms d’homologation l’avait manquée.
arrhub.comArrHub Alerts, 20 September 2026Documentary No. 01, HTML and PDF
Corrigé le 24 septembre 2026
The licence register will not say what the conditions are, when they were imposed, or what would discharge them. The conditions themselves are printed in a different Health Canada record, the Regulatory Decision Summary, for three of the five licences: Volt (RDS16908), Varipulse (RDS17224) and Globe (RDS17357). Farapulse's latest summary (RDS17368) states that the terms and conditions issued before 1 January 2026 continue to apply, without listing them, and PulseSelect's three summaries print none.
Auparavant : The register will not say what the conditions are, when they were imposed, or what would discharge them. That information exists only in the sponsor's own licence correspondence.
Health Canada's Drug and Health Product Register publishes a Regulatory Decision Summary for the applications the Medical Devices Bureau decides. Thirteen name one of the five licences; the four dated 2026 are typed "with conditions", and three of them print the terms and conditions of the licence as numbered lines. The sentence was written from the licence register alone, without reading that second register. A new Table 5 transcribes the conditions as printed, with one citation per summary checked by the gate, and the Not covered section no longer says the document makes no statement about what the conditions are. The PDF cover reads Revised 24 September 2026.
Documentary No. 01, executive summary, section 4 and Not covered, HTML and PDF
Corrigé le 24 septembre 2026
Records are classified as electrophysiology devices by the editor, working against a written protocol. Applicants are resolved to owning organisations through a verified alias table. From 24 September 2026, each classification records who confirmed it and which version of the protocol applied.
Auparavant : Records are classified as electrophysiology devices, and applicants are resolved to owning organisations, by trained reviewers working against a published protocol, with a monthly editor sample. Each decision records who confirmed it and which version of the protocol applied.
The database did not support the sentence. Classification is done by the editor alone, no monthly sample has been taken, and the 133 licences confirmed by 20 September 2026 carry no record of who confirmed them or under which protocol version; the re-ingestion of 20 September rewrote verified_by to the checker's name on every row. The record is mandatory from 24 September 2026 (ep_confirmed_by, ep_confirmed_method).
Corrigé le 24 septembre 2026
each confirmed record carries the keyword that made it a candidate. The method of confirmation is recorded in the database from 24 September 2026. For 62 of the 133 licences confirmed by 20 September, a review file in the ArrHub repository records that a language model proposed them and a person confirmed them; for the other 71, no record of the method was kept
Auparavant : each confirmed record carries the method that confirmed it
The database carries the candidate keyword (ep_candidate_reason) for every confirmed licence. The review file scripts/sql/tier-b-mdall-confirm.sql (commit de18027, 19 September 2026) names 62 of the 133 as proposed by a language model and confirmed by a person; the other 71 have no record, and the re-ingestion of 20 September 2026 rewrote verified_by on every row. From 24 September 2026 the record is mandatory (ep_confirmed_by, ep_confirmed_method). The PDF cover reads Revised 24 September 2026.
Corrigé le 22 septembre 2026 · Remplacé le 24 septembre 2026
Every pulsed field ablation catheter licensed in Canada is conditional
Auparavant : Every pulsed field ablation catheter and system licensed in Canada is conditional
Licence 115141 (Current PFA) is a Class III system licence with status I, Issued/Active, and names no catheter; the headline's own Table 1 contradicted it. A line under Table 1 now states this on every page that carries the claim, and the PDF cover reads Revised 22 September 2026.
Tel qu’imprimé dans le numéro : Corrigé le 22 septembre 2026 : le titre disait auparavant « sonde et système ». L’homologation 115141 vise un système et elle est en vigueur.
arrhub.comArrHub Alerts, 20 September 2026Documentary No. 01, HTML and PDF
Corrigé le 22 septembre 2026
Health Canada's register still carries seven Guidant company records, with 77 licences under them; every one is discontinued or cancelled, and no active electrophysiology licence sits under a Guidant name
Auparavant : MDALL still lists licences under Guidant Corporation and Guidant Advanced Cardiovascular Systems
The citation gate found no active licence linked to a Guidant company record. The seven company records and their 77 licences were read from the MDALL company and licence endpoints; 76 are status O and one is status C.
Tel qu’imprimé dans le numéro : Corrigé le 22 septembre 2026 : cette ligne disait auparavant « MDALL inscrit encore des homologations sous Guidant Corporation et Guidant Advanced Cardiovascular Systems ». Le registre compte sept fiches d’entreprise Guidant, avec 77 homologations sous elles, toutes abandonnées ou annulées ; aucune homologation en vigueur ne se trouve sous un nom Guidant.
Corrigé le 22 septembre 2026
Forty-six confirmed licences carry "ablation" in their licence names: three of the pulsed field systems (PulseSelect, Farapulse and Varipulse) and 43 radiofrequency and cryoablation catheters, consoles and cables
Auparavant : Forty-seven confirmed licences carry "ablation" in their names; four are the pulsed field systems above
The citation gate counted 46 licence names containing "ablation" on the verified view. Kardium's Globe is named GLOBE PULSED FIELD SYSTEM, so it was miscounted.