Not to be pedantic, but the article is wrong. The filing explicitly only mentions FDA clearance not approval.They did get FDA approval per the article but their complaint is that they are dependent upon Apple devices to trigger their own device's operation and Apple has changes its API so they can no longer trigger that process. If I were making a medical device that was dependent on Siemens imaging equipment to trigger my operation I wouldn't be at all surprised if Siemens unilaterally changed their interfaces either. That would have been a risk I took on by making my device dependent upon another manufacturer without contractual agreements in place to support said interface. They're taking a shot in the courts but it won't work out in their favor.
edit: typo
The two are often confused with one another and marketing often relies on that confusion.
There’s a significant difference between the two. CNET writes about the difference here, but if video is more your thing, Last Week Tonight with John Oliver had an item on it as well.
That said, the difference between the two is irrelevant for the argument you made or the case as a whole, rather a general PSA.
I believe you’re right in that this is going nowhere, not in the least because they saw Epic’s narrow definition of a relevant market that has already been labelled as “novel” and thought “hold my beer” and decided to argue the following two relevant markets in their filing:
ECG-capable smartwatches are a relevant market of their own
This means watchOS heartrate analysis apps constitute a relevant product
market.
The beauty/downside of the American common law system is that you have more flexibility in making novel arguments, and nothing is certain.
That said, it’s highly unlikely that a court will go along with a relevant market consisting only of ECG-capable smartwatches as opposed to smartwatches in general, and it’s even less likely that specifically heart rate analysis apps will be deemed a relevant market.