BTL said on October 1 that FDA cleared three new uses for EXOMIND, its noninvasive brain stimulation platform. The clearances cover depressive episodes and anxiety symptoms in adults with major depressive disorder who failed a prior antidepressant, adjunctive treatment of obsessive compulsive disorder in adults, and adjunctive treatment of major depressive disorder in patients aged 15 to 21.
EXOMIND came to the US market in 2025 for adult major depressive disorder. BTL also added an intermittent theta burst protocol with sessions as short as three minutes, and a dual applicator. The company did not publish K numbers for any of the three clearances.
Note the shape of the adolescent claim: 15 to 21 straddles the pediatric line, and the indication is adjunctive rather than standalone. That is the usual way a neurostimulation sponsor gets into a younger population without running a full pediatric program, and it is worth reading closely if you are scoping one. BTL is based in Marlborough, Massachusetts and has been selling devices since 1993.