Artificial Intelligence in Medical Technology Myths and Facts

The 20th edition of the EY Pulse of the MedTech Industry Report captures the medical devices sector at both a high point and a turning point.

In this op-ed published in Medtech Insight, Justin Klein, MD, JD, explains how the proposed RAPID coverage pathway could accelerate Medicare access to breakthrough medical technologies and why targeted refinements are essential to its success.

WASHINGTON, D.C.—AdvaMed, the Medtech Association, today announced that its Digital Health Tech Board of Directors has approved voluntary Data Access Principles & Best Practices to help medical technology companies and health systems collaborate on responsible data access, use, and protection. The framework puts patient trust at the center of efforts to improve care, support research, and advance innovation, including artificial intelligence.

Join McDermott Will & Schulte Law in this session that will explore explore practical guidance for companies developing connected medical technologies navigating SEPs, FRAND licensing and patent pools.

BOSTON—AdvaMed, the Medtech Association, concluded The MedTech Conference 2026, convening more than 4,470 attendees from 2,050 companies from 40 countries for the global medtech industry’s premier annual gathering.

WASHINGTON—AdvaMed, the Medtech Association, encouraged the U.S. Food and Drug Administration (FDA) to build on its existing regulatory framework for generative AI (GenAI)-enabled medical devices rather than create new frameworks that could impede the innovations serving patients. The comments respond to FDA’s discussion paper (Docket No. FDA-2026-N-7874) seeking early input on assessing risks and evaluating GenAI devices before marketing and post-market monitoring.

BOSTON—AdvaMed, the Medtech Association, brought together innovators and industry leaders at The MedTech Conference 2026, held October 18-21 in Boston. The conference recognized companies developing technologies to address a diverse array of patient needs through awards offered in several competitions and programs.

BOSTON—AdvaMed, the Medtech Association, convened the 13th Annual Symposium on Pediatric Device Innovation on October 18 at The MedTech Conference 2026 in Boston. In collaboration with the five U.S. Food and Drug Administration-funded Pediatric Device Consortia and with support from the Mussallem CHD Alliance, the symposium brought together innovators, clinicians, regulators, investors, and patient advocates to address the evidence and access barriers that keep promising technologies from reaching children.