Guardant Health’s Shield™ Blood Test Approved by FDA as a Primary Screening Option, Clearing Path for Medicare Reimbursement and a New Era of Colorectal Cancer Screening

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.

WASHINGTON — AdvaMed, the Medtech Association, today announced that John Jaeckle, Chief Regulatory Affairs Strategist, at GE HealthCare, is the recipient of the 2026 AdvaMed Imaging Röntgen Award. The award recognizes Jaeckle’s more than 25 years of leadership in medical imaging regulation and standards development, including his work to advance computed tomography technology, performance and regulatory alignment in the United States and worldwide.

WASHINGTON, D.C.—AdvaMed, the Medtech Association, today recommended refinements the Centers for Medicare & Medicaid Services (CMS) could make to help its proposed Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway deliver more timely access to breakthrough medtech for Medicare beneficiaries.