Medtech Matters

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss questions raised by news of medical technology being rolled out to help battle the COVID-19 virus. Topics such as what Emergency Use Authorization means to how non-manufacturers of medical devices can now produce products for the effort such as ventilators. Specifically, we address a number of questions, including:What is coronavirus?We’re hearing quite a bit about Emergency Use Authorization, primarily around tests for COVID-19. What does that mean exactly?Does EAU lower the regulatory burden compared to other pathways to market?To address the need for ventilators, companies like Ford and GM are changing over production to help. How does this happen when the FDA has likely never stepped foot into these facilities?With all the rushed approvals/clearances of new medical supplies, is there a concern regarding safety?What is the situation for companies with existing devices (already on market) t