Soterix Medical, Inc. (SMI), announces that it has received Singapore’s Health Sciences Authority (HSA) approval for its non-invasive therapeutic medical device. This approval allows Soterix Medical to immediately market its products based on its proprietary transcranial Direct Current Stimulation (tDCS) technology in Singapore. The therapy works by delivering a mild electrical current through electrodes placed on the head relieving the symptom of Major Depression using the Depression tDCS-LTE™ treatment or Fibromyalgia using the PainX™ treatment. Patients who have not responded well to drug treatment are candidates for Depression tDCS-LTE or PainX treatment where typical adverse events are limited to mild itching and tingling. The therapy is available as a 20-30 minute in-office treatment.
"South East Asia is an important region for Soterix Medical", according to Chief Product Manager, Kamran Nazim. "HSA approval reflects our mission to deliver our treatment technologies worldwide and will build on our momentum and presence in these rapidly developing markets. This approval is a milestone toward securing approvals across Asia as a whole, including Japan, South Korea, China, and other countries to meet the rapidly escalating demand for advanced device-based therapies in the continent."
Renato Moratore, VP Regulatory Affairs added, "There is currently no medical device meeting the risk-benefit profile of Soterix Medical PainX™ and Depression tDCS-LTE™ treatment. We are pleased to secure approval for the benefit of the region's physicians and patients. Soterix Medical representatives throughout South East Asia remain committed to ensure every customer receives timely and insightful product support, consistent with Soterix Medical's standing as the international leader in non-invasive neuromodulation."
Similar to clinical approvals in other countries, Singaporean healthcare providers can now access the Soterix Medical Treatment Partnership Program. Interested parties should contact Soterix Medical (at email@example.com) for an in-depth support package including specialized education, on-site staff training, treatment guidance, and on-going support.
CAUTION: tDCS is limited by Federal (or United States) law to investigational use only.
See full press release here
Contact: Max LoGuirato
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