The U.S. Food and Drug Administration has cleared several new medical devices to treat mental health conditions. Lumos Labs announced that they received clearance of Lumosity Rxopens in new window, a digital treatment for adults, ages 22–55, with ADHD. The product is an app-based treatment that delivers cognitive exercises to improve attention, working memory, and cognitive control. In the clinical trial, participants who used Lumosity over the course of 9 weeks experienced increased attention and reported improved quality of life compared with a control group.
Flow Neuroscience received approval for their at-home wearable device, Flow, for the treatment of adults with moderate to severe depressionopens in new window. Flow is a neurostimulation device that uses electrical current to stimulate the prefrontal cortex. In the clinical trialopens in new window, participants were randomly assigned to treatment with Flow or to a control condition with a sham stimulation device (e.g., a device that looked the same but did not deliver treatment). Depression scores were assessed before treatment and after 10 weeks of treatment. Compared with the control group, participants who used Flow experienced greater improvements in depression symptoms and 58% experienced remission at the end of 10 weeks.
Neuroliefopens in new window also announced that they received FDA approval of their at-home wearable device, ProlivRx, for the treatment of adults with major depressive disorder who have not experienced satisfactory benefit from antidepressant medication. ProlivRx works by delivering electrical pulses to stimulate specific neural pathways in the brain and is a noninvasive, non-medication treatment option. In the MOOD clinical trialopens in new window, participants treated with ProlivRx experienced a significant decrease in depressive symptoms compared with a control group. 21% of participants experienced remission after 8 weeks of treatment, and this increased to 32% in remission after 16 weeks of treatment.
These devices represent a growing trend of technology-enabled care that has the potential to augment and enhance care as usual. Learn more about the work of the Office of Health Care Innovation and APA Labsopens in new window to support the safe, responsible, and ethical use of technology in mental health care.
