WASHINGTON – The U.S. Food and Drug Administration has granted Breakthrough Device designation to Dthera Sciences’ digital therapeutic to treat patients with Alzheimer’s disease. The therapeutic, DTHR-ALZ, is intended to be a prescription digital therapeutic that will use artificial intelligence to automatically optimize Reminiscence Therapy based on various forms of biofeedback from the patient. Reminiscence Therapy is an evidence-based psychosocial intervention that has been shown in clinical trials to improve symptoms of the disorder, but the therapy’s adoption has been limited because of the investment of caregiver time and resources, according to the Alzheimer’s Association. DTHR-ALZ will seek to provide Reminiscence Therapy with more frequency, consistency and personalization, while requiring minimal investment of time and resources. “While we feel this ground-breaking recognition validates Dthera’s mission to positively impact the lives of those affected by the disease, it also represents a meaningful advance for the entire digital therapeutic sector,” said Edward Cox, CEO of Dthera Sciences, a digital therpeutics company focused on seniors and those with neurological diseases. Cox said that if approved, DTHR-ALZ would become the first non-pharmacological prescription treatment for the symptoms of Alzheimer’s disease. DTHR-ALZ is not yet available for commercial use in the U.S.
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