Good news indeed and a long time coming. I agree that the hard...

Good news indeed and a long time coming. I agree that the hard work really starts now, ultimately they still have a modest data set and will need to convince reimbursement agencies as well as the oncology community in markets where health systems are on their knees even at the best of times. But this is a start and we will now be able to witness their commercial competence.

Question: has anybody heard of breakthrough designation for a device in Europe with CE mark? I could find nothing about it online, only thing I found was for FDA which we all know about. And if breakthrough designation in EU is correct, what does it mean?

I know everybody is probably celebrating but the company will really need to watch how it communicates its data, especially in the market with competitors, regulators, lawyers and others watching. It's quite naughty to claim doubling of survival and then reference that to a study from 2011 which shows nothing of the sort. Pedantic possibly, but it won't do much for their credibility if they're caught out for false advertising.