Medtronic wins FDA clearance for 1st insertable cardiac system for children

The FDA cleared the first pediatric insertable cardiac system for approval Sept. 20. 

With the federal agency's premarket notification 510(k), Medtronic's system is cleared for patients older than 2 years old who have heart rhythm abnormalities and need long-term monitoring, according to a Medtronic news release. 

The device has been commercially available since 2020 and is currently in the FDA's approval process for use in pediatric populations.

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