Medtronic Gets Expanded Clearance for Pediatric Heart Monitor

Medtronic has received an expanded FDA clearance for its Linq II insertable cardiac monitor system. The device is now cleared for use in pediatric patients over the age of two who have heart rhythm abnormalities and require long-term continuous monitoring.

The monitoring is about one-third the size of a AAA battery and has a battery life of up to 4.5 years. The implantable device does not interfere with daily activities such as showering, bathing or swimming, the company said.

The system also includes the Medtronic’s AccuRhythm software which uses artificial intelligence to assess heart rhythm event data collected by the device. The algorithms provide information to help physicians better diagnose and treat the abnormal heart rhythms.

The Linq II is the first insertable cardiac monitor to be FDA-cleared for this patient population.