Device Week, 11 November 2021–Long-Awaited Software Guidance Released; FDA Panel Talks Stent Safety

On this week’s podcast: The US FDA finally issued a draft guidance for medical software in the premarket space, while an agency panel meeting focused on the safety of graft stents. Medtech Insight articles addressing topics discussed in this episode: • FDA’s SaMD/SiMD Guidance Could Mean Documentation Headaches For Some Software Makers, Attorney Says • Bleeding Risks Still A Concern For Patients With Endologix Stent Grafts: FDA Advisory Panel