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 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).
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.
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.
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.
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.
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.
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.