Medtronic plc (Dublin, Ireland) announced it has received U.S. Food and Drug Administration (FDA) clearance and CE Mark approval for its LINQ II insertable cardiac monitor (ICM) with remote programming, which enables clinicians to optimize device settings without the need for patients to return to the office or hospital.
LINQ II is a small (one-third the size of a AAA battery), wireless ICM for patients with abnormal heart rhythms who experience infrequent symptoms including dizziness, palpitations, syncope (fainting) and chest pain, thereby requiring long-term monitoring or ongoing management.
The company says that the LINQ II system also delivers improved device longevity (4.5 years) compared to other ICMs and enhanced accuracy to correctly detect abnormal heart rhythms.
The device will be commercially available in the U.S. and Europe later this summer.
