Theranica received FDA approval for its smartphone-controlled electroceutical for the acute treatment of migraine.

This is yet another digital therapeutic that received approval on the basis of a placebo-controlled clinical trial (another noteworthy example is Pear Therapeutic's offering, in collaboration with Novartis/Sandoz).

It appears that we are seeing the beginning of a more stringent approach for digital health and therapeutics development, including multi-center, placebo-controlled clinical trials. It will be exciting to see the first head-to-head trial of a digital Tx vs. a classical pharmaceutical, as well as the combination of digital and classical therapy in a trial.

It will be interesting to see how the payors are going to react to this change in the landscape.