The company is developing the first light-based, at-home device used as an add-on therapy for increasingly prevalent Parkinson’s disease 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 Article
Director, Industry Partnerships & Senior Market Analyst
20 Years of Experience
@Tracy_Schaaf's 20+ years of experience in the global medical device market analysis space brings a seasoned, multi-faceted perspective to the MedTech Strategist team. As a senior writer/market analyst, she contributes regularly to the company’s newest publication, MedTech Strategist Market Pathways: Global Regulatory, Reimbursement & Policy Review. Her coverage includes emerging regulatory, reimbursement, and market access trends, pioneering companies that are forging new pathways through the increasingly complex global medtech landscape, and the innovators who are working to bring novel, life-saving devices to market.
Tracy also developed and writes regularly for the popular “In MedTech History” series on the company’s Community Blog, where she highlights the trailblazing originators of today’s greatest medical device achievements. In addition, she manages MedTech Strategist’s important collaborations with top-tier global co-promotional partners including AdvaMed, the Irish Medtech Association, MedTech Europe, and many others across the device space.