BD Unveils Nebraska-Based Manufacturing Capacity to Support U.S. Vaccination Agility and Preparedness

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.

The State Medtech Alliance (SMTA) connects state and regional medtech associations across the U.S. to share best practices, coordinate advocacy, and improve patient access to medical technology.

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.

Behind every policy conversation is a patient waiting for access to the care and technology they need. In this edition of AdvaMed in Action, Bobby Patrick explores how collaboration among patient advocates, medtech companies, state partners and policy leaders can help advance patient access and turn shared priorities into meaningful action.

Join industry leaders for the in-depth Medical Device Submissions Workshop series to receive real-world case studies, timely submissions tips, and best practices.