Device Approval
Remote electric neuromodulation device approval extended to treatment of chronic migraine
The FDA has expanded the approval for Nerivio, a wearable remote electrical neuromodulation device controlled by a smartphone app, to treat chronic migraine in adults aged 18 years and older.
Nearly 20% of therapeutic devices cleared without pivotal clinical study
Almost 20% of moderate-risk, nonimplantable, nonlife-sustaining therapeutic devices cleared by the FDA through its de novo pathway did not undergo a pivotal study, data show.
FDA approves next-generation LAA closure device for nonvalvular AF
The FDA has approved a second-generation left atrial appendage closure device for patients with nonvalvular atrial fibrillation, Boston Scientific announced.
Mapping algorithm for stable, transient arrhythmias nets FDA approval
Acutus Medical announced the FDA clearance of a new algorithm for the mapping of stable and transient arrhythmias.
Trial to evaluate pulsed field ablation for AF
Medtronic announced that the FDA has approved an investigational device exemption trial to assess the safety and effectiveness of a pulsed field ablation system for the treatment of patients with atrial fibrillation.
Two-lead version of implantable pulse generator for HF garners approval
Impulse Dynamics announced that a two-lead version of its implantable pulse generator to deliver cardiac contractility modulation therapy to patients with HF has been approved by the FDA.
FDA clears second interoperable insulin pump
The FDA cleared Insult to market its tubeless Omnipod DASH Insulin Management System as an integrated insulin pump, allowing it to be part of an interoperable, automated insulin delivery system, according to an industry statement released Monday.