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ArrHub

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Alerts

The weekly record of verified electrophysiology decisions

An issue lists the week’s FDA decisions and Health Canada licences for arrhythmia devices, verified against the agency record under the published method and resolved to the owning company. The identifier on a line links to the agency record. Each issue is free in a Nutshell: the title, the finding, the week’s counts and the finding’s agency link. The full issue is in ArrHub Alerts Premium, by email. The sample issue is free in full.

  1. 29 September 2026

    Canada licensed six pulsed field devices a median of 84 days after the FDA

    Health Canada licensed Varipulse (licence 111495) on 11 July 2024, 118 days before the FDA approved the Varipulse platform. Affera's licence (115505) followed its FDA approval by 587 days. Across the six confirmed pairs, the median gap is 84 days after the FDA decision.

    In a Nutshell, free. The full issue is in ArrHub Alerts Premium.

  2. 20 September 2026

    Six pulsed field ablation devices hold Class IV licences in Canada

    Six 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.

    Full sample, free to read.