China Regulatory Workshop
Get the latest on new policy updates and guidance for the clinical evaluation of medical devices.
Regulatory Affairs
Learn more about our Regulatory Affairs work.
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
Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced the U.S. Food and Drug Administration (FDA) has approved the company’s Shield™ blood test for colorectal cancer (CRC)…
AdvaMed® Cybersecurity Summit
Join us in Washington, D.C. for our Cybersecurity Summit that will address the future of medical device cybersecurity and changes in the industry landscape related to FDA requirements.
MedTech Reimbursement Playbook
Learn the basic principles of how medical technologies are covered and paid by insurers and the challenges medtech companies face.
Successful Market Access of SaMD & MDSW: Decoding the Confusion in MedTech Software Development
Artificial intelligence has been in the spotlight recently, but it is not a new concept to the Food and Drug Administration (FDA) or the medtech industry. AI advancements in the…
PFAS in Medtech
Per- and polyfluoroalkyl substances, known as PFAS, are a broad class of over 12,000 substances that are found in a variety of consumer, commercial and industrial products, including medical devices…
AdvaMed® Anticipates EtO Sterilization Rule, Voices Concern About Impact on Patient Care
By Friday, March 1, the Environmental Protection Agency is expected to finalize its regulation for the ethylene oxide (EtO) sterilization of 20 billion, or half, of all medical devices in…
Artificial Intelligence in Medtech
Artificial intelligence has been in the spotlight recently, but it is not a new concept to the Food and Drug Administration (FDA) or the medtech industry. AI advancements in the…
Artificial Intelligence in Medical Technology Myths and Facts
Outlining the facts and dispelling myths will inform policymaking to avoid overlap with current regulations and preserve the broad capacity of innovation to help patients.
Principles for Artificial Intelligence in Medical Technology
This document provides the medical device industry’s foundational principles for artificial intelligence in medical technology. These principles will guide further innovations, policymaking, and regulations in AI-enabled medical technology.