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.