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People with Parkinson’s discuss ways they cope with their disease

PhotoPharmics recently learned the depth and breadth of ways people with Parkinson’s cope with the devastating disease when they asked a large group of them a simple question: What do you do to take your mind of Parkinson’s disease? Read more >

Survey reveals Parkinson’s disease non-motor symptoms manifest first

Parkinson’s disease is best recognized by its motor symptoms—namely tremor. But it surprised our research team, and it may surprise you as well, to learn that 87 percent of people with Parkinson’s surveyed said they noticed non-motor symptoms first; and 78 percent said they noticed non-motor symptoms even before they were formally diagnosed with Parkinson’s. Read more >

FDA Breakthrough Devices Program nears 300 designations

FDA has granted 50 breakthrough device designations so far this year, an agency spokesperson told MedTech Dive on Tuesday, bringing the total number given throughout the program’s history to 298.​

PhotoPharmics. The Salt Lake City-based company obtained breakthrough status for its non-invasive phototherapy device intended as an adjunct treatment to help people with Parkinson’s disease improve overall function.

Phase 3 Trial Tests PhotoPharmics’ At-home Light Therapy to Ease Parkinson’s Symptoms

A new Phase 3 clinical trial will test PhotoPharmics‘ light-based, at-home therapy device — called Celeste — for Parkinson’s disease. The “Celeste Light for PD Trial” — a collaboration between PhotoPharmics and the Center for Health + Technology (CHeT) at the University of Rochester Medical Center — will be conducted at home via telemedicine and is set to begin in the fall. More  information is available here.

PhotoPharmics: Shining a Light on Parkinson’s Disease With a Breakthrough Device

The company is developing the first light-based, at-home device used as an add-on Parkinson’s disease therapy to receive a 510(k) de novo classification and Breakthrough Device designation from FDA. Importantly in light of the COVID-19 pandemic, its upcoming Phase III trial will be remote, and then the next hurdle will be EU MDR. Read more >

FDA Names Spectramax Light Therapy ‘Breakthrough Device’ for Parkinson’s

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.

Spectramax Light Therapy Shows Promise in Easing Parkinson’s Non-motor Symptoms

PhotoPharmics’s Spectramax light therapy reduces disease severity, lessens non-motor symptoms, and improves the quality of life of Parkinson’s patients, according to recent results of a controlled clinical study.