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srcoffee t1_j5ojevm wrote

Reply to comment by [deleted] in Garmin adds FDA-cleared EKGs to its Venu 2 Plus smartwatch | Garmin is shoring up its lifestyle offerings by adding this advanced health feature to its smartest device. by chrisdh79

FDA-cleared is the important distinction in this case because it’s a Class II product. FDA approved is more for drugs and vaccines. (Class III)

Low risk devices (Class I) don’t need clearance or approval.

Here’s one source: approved vs. cleared

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