The United States Food and Drug Administration (FDA) has granted breakthrough device designation to PhotoPharmics‘s light-based, at-home device as an add-on therapy for Parkinson’s disease.
This designation is given to medical devices with the potential to offer more effective treatment for life-threatening or debilitating diseases. It grants the company access to experts at the FDA during development, and paves the way for prioritized review of approval requests
The trial enrolled 92 participants with Parkinson’s (45 years or older) across 3 research centers in Europe and the U.S (Amsterdam University Medical Centers, Massachusetts General Hospital, Boston, and Aspen Clinical Research, in Utah). 45 participants were randomized to the Spectramax treated groups, while 47 were randomised to the placebo light group.
The treatment group were given the Spectramax Light Therapy Lamp, which is a table-top device emitting blue/green narrow bandwidth LED light (λ = 450 – 570 nm, 950 Lux).
I was in the other clinical trial that used 1000 lux white light. It will be interesting to compare the two trials. It's certainly easier to get a white light box. I'm using this for 30 minutes a day: amazon.com/gp/product/B081M...
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