US and European approval for Medtronic’s LINQ II insertable cardiac monitor

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Medtronic’s LINQ II ICM

Medtronic today announced that it has received US Food and Drug Administration (FDA) clearance and CE mark approval for its LINQ II insertable cardiac monitor (ICM) device with remote programming. According to a press release from Medtronic, the LINQ II enables clinicians to optimise device settings without the need for patients to return to the office or hospital.

The LINQ II system delivers improved device longevity compared to other ICMs and enhanced accuracy to correctly detect abnormal heart rhythms, simplifying the diagnosis and monitoring of patients, the press release added.

LINQ II is described as a small, wireless ICM for patients with abnormal heart rhythms who experience infrequent symptoms including dizziness, palpitations, syncope and chest pain, requiring long-term monitoring or ongoing management. The device will be commercially available in the USA and Europe later this summer.

“In the current COVID-19 environment, the LINQ II system offers patients a seamless way to experience ongoing connectivity between their device and their physician, while reducing the need for in-office visits,” said Rob Kowal, chief medical officer of the Cardiac Rhythm and Heart Failure division, which is part of the Cardiac and Vascular Group at Medtronic. “LINQ II gives physicians actionable data to help diagnose underlying heart conditions and define treatment protocols for patients with atrial fibrillation (AF) or other abnormal heart rhythms.”

The LINQ II device incorporates many of the features of LINQ with TruRhythm plus further developments including remote programming and patient management, compatibility with the MyCareLink Heart mobile app and an extended duration of continuous monitoring.


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