www.fdanews.com/articles/197965-medtronic-earns-clearances-for-insertable-cardiac-monitor
Medtronic Earns Clearances for Insertable Cardiac Monitor
July 8, 2020
Medtronic’s LINQ II insertable cardiac monitor has received FDA clearance and a CE mark in Europe for treatment of patients with abnormal heart rhythms who experience infrequent symptoms, such as dizziness, palpitations, fainting and chest pain.
The wireless device is about one-third the size of a AAA battery and can be remotely programmed by clinicians without the need for patient visits.
Patients can either send data collected by the device using a smartphone app or a home communicator device.