Cala Health recently published a post-market study showing that its wrist-based wearable to treat essential tremor effectively reduced patients' tremor power with no loss of effect over time. Most patients involved in the study reported improvement in daily activities, such as eating, drinking, texting and writing.
The regulatory agency said there are psychological and physical risks associated with use of such devices, including depression, anxiety and what appears to resemble PTSD. In addition to psychological effects, there have been reports of burns, tissue damage and shocks.
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.