Event Speaker
Adrienne Lenz, MS
Principal Device Regulatory Expert Hyman
Phelps & McNamara PC
Adrienne Lenz is a principal medical device regulatory expert with Hyman, Phelps, & McNamara, P.C. In this role, she provides consulting to medical device, pharmaceutical, and combination product manufacturers. She assists clients with a wide range of pre and postmarket regulatory topics including developing regulatory strategy, preparing regulatory submissions, drafting regulatory policies and procedures, reviewing design documentation, and addressing enforcement matters. Ms. Lenz has also held positions in regulatory affairs, quality assurance, and test engineering at GE Healthcare and Smiths Medical.
Sessions
Imaging at the Crossroads: Current Regulations and the Future of AI in Diagnostics
Explore the evolving regulatory landscape shaping the intersection of artificial intelligence and healthcare across enterprises. This session dives into key regulations like HTI-2, Lab Developed Tests (LDTs), Section 1557 for AI/DEI, and the implications of the “CDS dead?” debate. Gain insights into how these regulations impact diagnostic workflows, enterprise imaging strategies, and the future of…