• 09 Mar 2023
• Admin
• News Article

Us Fda Grants Breakthrough Device Designation To Sooma Medical

Sooma Medical, A Medical Device Company Based In Finland, Announced That Its Portable, Patient-Administered Neuromodulation Device To Treat Depression Receives Us Food And Drug Administration (Fda) Breakthrough Device Designation.This Revolutionary Treatment Utilises A Mild Electrical Current To Stimulate Targeted Brain Areas, Significantly Improving Depressive Symptoms. The Fda'S Breakthrough Designation Is Reserved For Novel Therapies That Show Significant Potential To Provide A Substantial Improvement Over Existing Options For Severe Or Life-Threatening Conditions."We Are Thrilled To Receive This Breakthrough Designation From The Fda," Said Tuomas Neuvonen, Ceo Of Sooma. "This Is A Huge Step Forward For Our Company And, More Importantly, For The Millions Of People Suffering From Depression. We Are Committed To Making This Innovative Treatment Accessible To Patients In The Us As Quickly As Possible."Depression Is A Serious Mental Health Condition That Affects Millions Of People Worldwide. Current Treatment Options, Such As Antidepressants And Psychotherapy, Can Be Effective But Also Have Limitations. Sooma Depression Therapy Offers A New, Non-Invasive Alternative That Has The Potential To Significantly Improve The Lives Of Those Suffering From Depression.Sooma Medical Is Dedicated To Developing Innovative And Accessible Solutions To Improve The Lives Of People Affected By Mental Health Conditions. The Company Continues To Work Closely With The Fda To Bring This Treatment To The Market And To Make It Available To More Patients As Soon As Possible.Sooma Depression Therapy, Already Approved In The Eu, Is An Effective First-Hand Treatment Option For Depression Used By Hundreds Of Patients Annually In More Than 30 Countries. The Therapy, Which Is Painless And Involves No Medication, Is Always Prescribed By A Medical Professional.The Treatment Consists Of Daily 30-Minute Sessions For A Minimum Of Three Weeks. It Can Also Be Used As A Stand-Alone Treatment Or As An Add-On Therapy Along With Other Types Of Treatment, Such As Pharmaceuticals, Without The Risk Of Dangerous Drug Interactions.Most Patients Can Feel Relief From Their Depressive Symptoms Around The Third Week Of Treatment. According To Sooma'S Post-Market Data, More Than Half Of Patients Achieve A Complete Clinical Response, Meaning A 50% Or Greater Improvement In Their Depressive Symptoms After The Treatment.Sooma Medical Is A Finnish Medical Device Company Established In 2013, Which Works Closely With Leading Experts In Psychiatry And Clinical Neurophysiology To Develop Effective Treatment Solutions For Health Conditions In These Areas