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.
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
433 FDA decisions and 135 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 |
|---|---|---|---|---|
| 2026-09-04 | Boston Scientific | FARASTAR™ Pulsed Field Ablation (PFA) Generator; FARASTAR™ Mapping System Module (MSM); FARASTAR™ Recording System Modul truncated in FDA record | P230030/S024 | PMA supplement |
| 2026-09-04 | Peerbridge Health | Peerbridge COR MDx (Cor MDx) | K253529 | 510(k) |
| 2026-09-03 | Abbott | Therapy™ (including Bi-Directional and 4mm Thermistor) Ablation Catheter | P040014/S052 | PMA supplement |
| 2026-09-03 | Abbott | Therapy™ Dual-8™ Ablation Catheter | P040042/S060 | PMA supplement |
| 2026-09-02 | Johnson & Johnson | THERMOCOOL SMARTTOUCH® SF Catheter | P030031/S142 | PMA supplement |
| 2026-08-28 | Medtronic | LINQ II Insertable Cardiac Monitor (ICM) (LNQ22) | K262735 | 510(k) |
- Boston ScientificFARASTAR™ Pulsed Field Ablation (PFA) Generator; FARASTAR™ Mapping System Module (MSM); FARASTAR™ Recording System Modul truncated in FDA record
- Peerbridge HealthPeerbridge COR MDx (Cor MDx)
- AbbottTherapy™ (including Bi-Directional and 4mm Thermistor) Ablation Catheter
- AbbottTherapy™ Dual-8™ Ablation Catheter
- Johnson & JohnsonTHERMOCOOL SMARTTOUCH® SF Catheter
- MedtronicLINQ II Insertable Cardiac Monitor (ICM) (LNQ22)
Four of the latest decisions shown. Decisions dated since 17 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.