A San Diego based developer, Dthera Sciences, has recently been granted Breakthrough Device designation from the FDA for a digital therapeutic device for Alzheimer’s. The device, DTHR-ALZ, delivers therapy through a custom tablet with a front-facing camera that displays content such as photos of loved ones and memories uploaded by the patient’s family. As the patient enjoys the memories, an AI system collects data through the camera to adjust the content to the viewers’ emotions.
By the 21st Century Cures Act, the Breakthrough Devices Program aims to streamline new medical technologies that provide improved treatment and diagnosis options for diseases that lack therapeutic options. This designation does not indicate clearance; however, the FDA works with those sponsoring the device to reduce the time and money spent seeking approval.
This device follows Pear Therapeutic’s reset as a pioneering digital therapeutic product that received this designation. DTHR-ALZ is an intervention “intended to mitigate the symptoms of agitation and depression associated with major neurocognitive disorder of the Alzheimer’s type,” as per the proposed instruction for use.
“Obviously I’m biased, but I think this is great move by the FDA because it shows that they care for these patients and their families,” said Dthera Sciences CEO Edward Cox. “To our knowledge, we’re the only non-pharmalogical, non-pharmaceutical product to ever be given this designation for the Alzheimer’s indication. That means that they’re looking to make a difference with this public health crisis, as Alzheimer’s is the only top-ten, leading cause of death that has no cures and can’t be treated.”
Cox stated that the devices technology has been in the development process for approximately four years and is similar to ReminX, Dthera Sciences product that gives seniors images of their past to alleviate anxiety and solitude. Using this products development strategy and studies published of reminiscent therapy, a trail was conducted with the University of California San Diego to test DTHR-ALZ’s efficacy. Cox said that after these trials, Dthera had enough confidence to bring the project to the FDA.
“For us, we have every reason to believe that this will be successful,” Cox said. “What we want to do is work closely with the FDA to guide a product that can consistently, repeatedly, and importantly, proven in a clinical trial, bring these patients back from the edge.”
@DtheraSciences Receives FDA Breakthrough Device Designation For Its Alzheimer’s Focused Development-Stage Product “DTHR-ALZ” https://t.co/OK4enECsZk
— Dthera Sciences (@DtheraSciences) August 23, 2018
Source: MobiHealthNews
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