August 10, 2018

360° view on regulations for medical devices in EU - US

Julie Carty

At HealthXL we empower innovators to solve healthcare problems through collaboration. On Wednesday, we hosted a webinar featuring one of our HealthXL Members - ICON plc. ICON plc is a clinical research organization (CRO) to the pharmaceutical, biotechnology & medical device industries. At the webinar, Dr. Dairine Dempsey, Vice President of Strategic Regulatory Affairs at ICON, a Ph.D. pharmacist, with over 15 years' experience as a pharmaceutical regulator, provided us with an overview of the regulatory landscape for medical devices in digital health.We were also hosting Prof. Brendan Buckley, Chief Medical Officer of ICON, who gave us an overview of ICON and Dr. Anand Iyer, Chief Strategy Officer of WellDoc, who are commercializing BlueStar, the first FDA-cleared mobile prescription therapy for Type 2 diabetes.

Five insights from the webinar: