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Home » Sooma wins FDA breakthrough nod for neuromod that treats depression

Sooma wins FDA breakthrough nod for neuromod that treats depression

March 6, 2023 By Sean Whooley

Sooma Medical neuromodulation kit for treating depression
The neuromodulation kit developed by Sooma. [Image courtesy of Sooma Medical]
Sooma Medical today announced that it received FDA breakthrough device designation for its neuromodulation device for treating depression.

The portable, patient-administered neuromodulation device utilizes a mild electrical current. It stimulates targeted brain areas resulting in a significant improvement in depressive symptoms.

“We are thrilled to receive this breakthrough designation from the FDA,” said Tuomas Neuvonen, Sooma CEO. “This designation recognizes that our device is a perfect solution, enabling a fast, effective and affordable treatment on a greater scale.

Neuvonen added that the company aims to make the treatment accessible to patients in U.S. “as quickly as possible.”

Sooma said its depression therapy offers a flexible treatment option with accessibility and affordability. It could benefit those underserved by medication or with limited access to psychotherapy.

The painless therapy involves no medication. It requires prescribing by a medical professional. The therapy features daily 30-minute sessions lasting a minimum of three weeks. Sooma said it also offers use as a standalone treatment or add-on therapy with pharmaceuticals.

According to the company, most patients feel relief around the third week of treatment. Postmarket data demonstrated that more than half of Sooma’s patients achieved a complete clinical response. That means a 50% or greater improvement in depressive symptoms after treatment.

Sooma said it plans to “work closely with the FDA” to bring the treatment to the U.S. market.

Filed Under: Bioelectronic Medicine, Food & Drug Administration (FDA), Neurological, Neuromodulation/Neurostimulation, Regulatory/Compliance Tagged With: Sooma Medical

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About Sean Whooley

Sean Whooley is an associate editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at [email protected].

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