By Beckie Fenrick, AlignRx Digital therapeutics (DTx) have been increasingly popular since smartphones and wearable tech became ubiquitous. The pandemic has set them on a trajectory for massive growth and mainstream adoption. Currently, there is inconsistency in how DTx are handled by payers and health plans, which sometimes treat them as medications. The manufacturer would have a role in this determination. The manufacturer submits the digital therapeutic for FDA review as a device, not as a drug.