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

We already know EKG is effective in diagnosing disease. This means they were able to show similar performance to existing EKGs and I think it’s kind of a big deal. I’ve gotten an FDA clearance and I can tell you believe it or not it means something and they don’t just hand them out.

E: if you think using the phrase FDA cleared is meant to be deceptive, please tell us what phrase would be more appropriate. It’s exactly the correct thing to say.