Connected devices, software, and digital therapeutics are disrupting the medical device space.
Medical devices are quickly evolving beyond just hardware as more medical device companies turn to software or mobile applications to increase consumer accessibility.
Digital therapeutics — such as Abilify Mycite, the ingestible sensor-embedded drug recently cleared by the FDA — are also helping expand the scope of medical devices.
The FDA’s definition of a medical device is an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, which is intended for use in the diagnosis, prevention, or treatment of disease, or intended to affect the structure or function of the body.
