BTL has received expanded FDA clearances for EXOMIND®, its noninvasive brain stimulation platform, adding new indications for obsessive-compulsive disorder (OCD), major depressive disorder (MDD) with comorbid anxiety, and adolescent patients aged 15–21.
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The expanded clearances also introduce an intermittent theta burst protocol, reducing MDD treatment sessions to as little as three minutes. BTL has additionally launched the EXOMIND® Dual Applicator, giving providers greater flexibility in targeting brain regions and tailoring treatment protocols.
EXOMIND initially entered the U.S. market in 2025 for adult patients with MDD. The new indications broaden the platform across additional conditions, patient populations and treatment approaches, extending its use beyond its original MDD indication.
The expanded FDA clearance strengthens EXOMIND’s position within BTL’s growing portfolio of noninvasive technologies and supports the company’s strategy of expanding access to brain stimulation across a wider range of clinical needs.
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