Sooma’s Depression Therapy Device Receives FDA Green Light

Sooma’s Depression Therapy Device Receives FDA Green Light, formerly reserved for treating severe pain and mobility issues, neurostimulation technology is increasingly being explored in other areas. The FDA has approved a number of systems to address incontinence, and now they’ve given the go-ahead to use technology developed by Theranica to cure and prevent migraines. 

A small but promising body of research suggests neurostimulation can be used to revive mobility in paralyzed limbs. Neuromodulation is increasingly gaining popularity as a therapy for major depressive disorder, albeit the FDA-approved systems for this purpose need in-clinic sessions. 

In this regard, Sooma Medical, a company that’s creating a neuro stim headset to provide its depression-targeting therapy to patients in the privacy of their own homes, has arrived on the scene.

The medical device manufacturer stated that the FDA has granted the company’s request for breakthrough device status because of the planned venue change. The approval establishes a formal line of communication between Sooma and the FDA and will expedite the examination of the firm’s future submission for FDA clearance.

Sooma CEO Tuomas Neuvonen remarked in a press statement, “We are committed to making this innovative treatment accessible to patients in the U.S. as quickly as possible.” In an effort to speed up the delivery of sorely needed therapies to the market, the FDA puts this tag on promising new technologies.

The Finnish firm uses tDCS (transcranial direct current stimulation) in its licensed therapeutic system in Europe. In this stimulation, electrodes deliver a modest electrical charge to targeted regions of the brain in an effort to disrupt and normalize nerve impulses associated with depression, hence alleviating associated symptoms.

How it works:

• The prescription-only technology is contained inside a flexible headgear that users may set up independently in a couple of minutes. After placing the electrodes into the elastic cap, overlaying them with hydrogel pads, and wetting them with saline solution, users slip the cap over their heads and may begin therapy right immediately.
• Initial plans called for 30-minute sessions (following which the electrodes would turn off automatically), five days a week, for three weeks.  Following that period, Sooma suggests, doctors should evaluate their patients’ improvement and decide if they want to continue neuromodulation treatment.

A little over 50% of the 410 individuals in a trial released last year experienced at least a 50% reduction in depression symptoms following an average of 16 sessions with the Sooma device. After the therapy period, over 95% of the patients reported at least a minimal improvement in their symptoms, and nearly one-fifth achieved complete remission.

Sooma isn’t the only company working to bring neuromodulation-based depression therapies to the comfort of people’s own homes. At least a couple more such systems have received breakthrough status from the FDA in recent years. Abbott got the green light from the FDA last summer for its deep brain stimulation technology.

In addition, the FDA gave Neurolief’s Relivion DP system a boost in 2020. This system relies on a headgear that is linked to a mobile application and cloud platform where clients and medical practitioners may track progress and make adjustments as necessary.

Also read, Theranica’s Nerivio Gains FDA 510(k) Nod For Migraine Prevention Device