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Washington, D.C.– AdvaMed, The Medtech Association®, today released the following statement from President and CEO Scott Whitaker on the U.S. Senate’s confirmation of Dr. Marty Makary to serve as commissioner of…
AdvaMed®’s medtech priorities for the 119th Congress highlight opportunities to address the most important issues facing patients and the medical technology industry today.
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)…
Learn the basic principles of how medical technologies are covered and paid by insurers and the challenges medtech companies face.
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…
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…
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 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…
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.
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.