As the pandemic has evolved, so has the FDA’s perspective on moving tests for COVID-19 from laboratories to rapid point-of-care and home settings. Critics contend that the agency hasn’t moved fast enough, but FDA diagnostics chief Timothy Stenzel emphasizes the need to balance multiple interests and that submissions for home tests have been slow in coming. FDA believes its latest template streamlining claims for asymptomatic screening should ease lingering industry concerns.Read Article
Senior Writer/Market Analyst
20 Years of Experience
Wendy writes on the medical devices and clinical diagnostics sectors, where she focuses on orthopedics/spine, molecular diagnostics and personalized medicine, clinical genomics, womens’ health/ femtech, and reimbursement/commercial strategy and innovation related to these specialties. She welcomes and encourages ideas and input from members of the MedTech Strategist Community.
Her career spans more than 20+ years as a top writer and manager focused on qualitative analysis of the global life sciences industry. She is Chair of Young Women in Bio Metro NY, an organization devoted to encouraging secondary students in the NY area to pursuit STEM careers and on the board of the Columbia Business School of Alumni Club NY