Arrhythmia devices entering the US and Canadian markets, every weekLes instruments pour l’arythmie qui entrent sur les marchés américain et canadien, chaque semaine
FDA and Health Canada records at device level, verified against the agency record under the published method and resolved to the company that owns it.
Free edition, weekly: the counts and one finding.
The register
1,175 decisions in ArrHub’s tracked FDA product codes; 137 licences confirmed as EP; 315 name matches pending review.
Alerts
The weekly record of verified electrophysiology decisions
Each issue lists the week’s FDA decisions and Health Canada licences for arrhythmia devices, verified and resolved to the owning company. Past issues are in the archive.
The current finding
Five of Canada's six pulsed field ablation licences show a conditional status
Eight licences on Health Canada’s active listing, first issued between December 2023 and July 2026.
Table 1. Pulsed field ablation licences on Health Canada's active licence listing
| Licence | Licence name | Manufacturer | Class | Status | First licence status date |
|---|---|---|---|---|---|
| 110572 | PULSESELECT PULSED FIELD ABLATION SYSTEM | MEDTRONIC INC. | IV | D | 2023-12-13 |
| 111047 | FARAPULSE PULSED FIELD ABLATION SYSTEM | BOSTON SCIENTIFIC CORPORATION | IV | D | 2024-04-04 |
| 111495 | VARIPULSE BI-DIRECTIONAL ABLATION CATHETER | BIOSENSE WEBSTER, INC. | IV | D | 2024-07-11 |
| 115142 | VOLT PFA CATHETER, SENSOR ENABLED | ABBOTT MEDICAL | IV | D | 2026-04-01 |
| 115505 | AFFERA ABLATION SYSTEM | MEDTRONIC INC. | IV | I | 2026-06-03 |
| 115863 | GLOBE PULSED FIELD SYSTEM | KARDIUM INC. | IV | D | 2026-07-29 |
| 111477 | TRUPULSE GENERATOR | BIOSENSE WEBSTER, INC. | III | I | 2024-07-05 |
| 115141 | CURRENT PFA | ABBOTT MEDICAL | III | I | 2026-04-01 |
Status: D = Issued/Conditional; I = Issued/Active. Health Canada licence status codes
Source: Health Canada MDALL, licence records 110572, 111047, 111495, 115142, 115863 and 115141, extracted 20 September 2026, records last refreshed by Health Canada 18 September 2026; licence records 115505 and 111477 and their device lists, read 24 September 2026.
First licence status dates are in the timeline above.
Registry
1,175 FDA decisions and 137 Canadian licences, with the agency record linked
Records link to the agency record they came from and name the company that owns them.
Latest verified FDA decisions
| Date | Organisation | Device | Identifier | Kind |
|---|---|---|---|---|
| 2026-10-03 | Boston Scientific | ALTRUA™ 2 (Model S722); ESSENTIO™ (Model L121); PROPONENT™ (Model L221); ACCOLADE™ (Model L321); ALTRUA™ 2 (Models S701, truncated in FDA record | N970003/S311 | PMA supplement |
| 2026-10-03 | Boston Scientific | VALITUDE™ (Model U125); VALITUDE X4 (Model U128); VISIONIST™ (Models U225, U226); VISIONIST X4 (Model U228) | P030005/S257 | PMA supplement |
| 2026-10-03 | Boston Scientific | ESSENTIO MRI (Model L131); PROPONENT MRI (Model L231); ACCOLADE MRI (Model L331); ESSENTIO™ MRI (Models L110, L111); PRO truncated in FDA record | P150012/S191 | PMA supplement |
| 2026-10-02 | Boston Scientific | EMBLEM™ Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) high voltage (HV) Capacitor | P110042/S216 | PMA supplement |
| 2026-10-02 | Boston Scientific | FARAPULSE™ Pulsed Field Ablation System (FARAWAVE™ Pulsed Field Ablation Catheter, FARASTAR™ Catheter Connection Cable, truncated in FDA record | P230030/S025 | PMA supplement |
| 2026-10-02 | Medtronic | Sphere-9 Catheter and Affera Ablation System | P240013/S031 | PMA supplement |
- Boston ScientificALTRUA™ 2 (Model S722); ESSENTIO™ (Model L121); PROPONENT™ (Model L221); ACCOLADE™ (Model L321); ALTRUA™ 2 (Models S701, truncated in FDA record
- Boston ScientificVALITUDE™ (Model U125); VALITUDE X4 (Model U128); VISIONIST™ (Models U225, U226); VISIONIST X4 (Model U228)
- Boston ScientificESSENTIO MRI (Model L131); PROPONENT MRI (Model L231); ACCOLADE MRI (Model L331); ESSENTIO™ MRI (Models L110, L111); PRO truncated in FDA record
- Boston ScientificEMBLEM™ Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) high voltage (HV) Capacitor
- Boston ScientificFARAPULSE™ Pulsed Field Ablation System (FARAWAVE™ Pulsed Field Ablation Catheter, FARASTAR™ Catheter Connection Cable, truncated in FDA record
- MedtronicSphere-9 Catheter and Affera Ablation System
Four of the latest decisions shown. Decisions dated since 22 April 2026, verified rows only. Organisation is the owning company where a verified alias resolves it; otherwise the applicant as the FDA names it.
Method and editor
Facts from the register, traceable to the record
Records come from a primary source: openFDA for 510(k) clearances and PMA decisions, and Health Canada’s Medical Devices Active Licence Listing for Canadian licences.
- Records are re-fetched and compared field by field against the agency record before publication, under the published method.
- Every row carries a link to the agency record it came from.
- Applicants and licence holders are resolved to the owning organisation through an alias table; an alias records the person or rule that set it.
- For acquisitions, the alias carries the filing that documents them.
- Unresolved names are shown as the register spells them.
ArrHub is edited by a Toronto-based intellectual property and technology lawyer with thirty years in patent licensing and technology law, who built the ingestion and verification pipeline that produces these records from public regulatory registers. ArrHub is published in Montreal and Toronto.