BTL Expands EXOMIND® Platform with New FDA Clearances

MARLBOROUGH, Mass., Oct. 1, 2026 /PRNewswire/ -- BTL Industries, a global leader in medical and wellness technologies, today announced expanded FDA clearances for EXOMIND(r), its noninvasive brain stimulation platform. EXOMIND(r) entered the U.S. market in 2025 through major depressive disorder (MDD) indications for adult patients. The new clearances expand its reach to additional brain targets and conditions, including obsessive-compulsive disorder (OCD), MDD comorbid anxiety, and extend care to adolescent patients. Additionally, EXOMIND(r) now offers an intermittent theta burst protocol with treatment sessions as short as three minutes, giving providers more ways to care for their patients. Further expanding the platform's capabilities, BTL introduces the new EXOMIND(r) Dual Applicator, broadening treatment possibilities and giving providers greater flexibility to personalize patient care.

EXOMIND®'s indications include:

• The treatment of depressive episodes and for decreasing anxiety symptoms for those who may exhibit comorbid anxiety symptoms in adult patients suffering from Major Depressive Disorder and who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode.
  
  
• Adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder.
  
  
• Adjunct for the treatment of Major Depressive Disorder in adolescent patients (15-21 years).

"OCD is among the most common mental health disorders worldwide, and it can turn everyday routines into a constant struggle," said Dennis Weimer, MD, a physician triple board-certified in Psychiatry, Consultation-Liaison Psychiatry, and Addiction Medicine. "In my practice, EXOMIND® has been an effective, comfortable treatment for patients with depression. Now I can offer another treatment option to adults whose lives are disrupted by OCD, while reaching more patients with depression and anxiety symptoms. With theta burst, a MDD treatment session can take as little as three minutes—making care easier to fit into their lives."

"When an adolescent is struggling with depression, it can affect every part of their life—school, friendships, family, and how they see their future," said Michelle Dees, MD, a board-certified psychiatrist. "For some, antidepressants haven't helped enough; for others, side effects can make an already difficult time harder. The clearance for adolescent patients gives clinicians another option to consider alongside existing treatment—and gives families another reason to hold on to hope."

"We're committed to expanding the capabilities of EXOMIND® and access to care," said Rohit Mishra, Vice President of Product Strategy & Business Development at BTL Industries. "We can now reach more people across age groups and address a broader range of needs, from mood and associated anxiety symptoms to behaviors that affect daily life. EXOMIND^® is a core part of our portfolio, and we will continue to invest in its future."

BTL will bring that wider conversation to communities during North American EXOMIND^® Days, October 13–15, 2026. Over three days, practices and communities will share real experiences, introduce new possibilities and create space for people to take the next step toward feeling calmer, more confident and more in control.

About BTL Industries

Founded in 1993, BTL is a global leader in medical devices, providing innovative solutions in dermatology, plastic surgery, med spas, orthopedics, joint and spine care, rehabilitation, dentistry, primary care, OB/GYN and more. With more than 200 patents and over 600 in-house engineers, BTL uses technology and science to advance medical treatments. Its portfolio includes EXOMIND®, EMSCULPT NEO®, EMFACE®, EXION™, EMSELLA® and others. For more information, visit BTLHealthcare.com.

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SOURCE BTL