Medtech Connect Episode 1: How Do We Regulate Software As A Medical Device?
Executive Summary
In the first episode of new podcast series Medtech Connect, Medtech Insight regulatory reporter Hannah Daniel interviews Foley and Lardner partner Kyle Faget about the complexities behind regulating software as a medical device (SaMD). Many companies are unsure if their software is even regulated by the FDA, let alone how to go about the clearance process. From managing cybersecurity risks to navigating digital health policy, Faget does it all, and she gives us insight into the regulatory landscape of SaMD in this month’s episode.
You may also be interested in...
What Can Tech Companies Teach Us About Clinical Trials?
Collaboration between tech companies and medical researchers may be the answer to modernizing clinical trials.
FDA Encourages Voluntary Device Shortage Reporting After PHE End
The FDA updated its policies regarding 506J notifications for device manufacturers at the end of the public health emergency.
Digital Health Roundup: HIMSS, Cardio Conversations, ChatGPT And New FDA Guidances
In this month’s Digital Health Roundup, Medtech Insight’s Marion Webb discusses how two medtech CEOs are and aren’t using ChatGPT in their businesses while Reed Miller talks about his “Cardio Conversations” podcast interviews with Quentin Blackford, CEO of iRhythm, and Rob Krummen, CEO of Vektor Medical. Washington, DC-based reporter Hannah Daniel reviews highlights from the HIMSS conference and the latest updates on FDA guidances.