CureApp
Also, CureApp is getting $77 million in investment from the Sawai Group as part of their license deal.
The new funds will be used to support the rollout of its hypertension DTx app.
The clearance represents what could be the world's first regulatory approval of a DTx app for hypertension treatment.
The app provides personalised treatment guidance to users based on their BP record, habit logs and behavioural changes.
Panelists at DTx East discuss the difference between 510(k) clearances and enforcement discretions, and why research should go beyond the FDA threshold.