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

Our in-depth device submissions workshops will provide real-world case studies, tips and best practices directly from FDA and industry experts.

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.

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 medtech industry are playing a major role in improving patients’ lives through innovative care, reduced healthcare costs, and improved patient outcomes.

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 the United States each year. AdvaMed President and CEO Scott Whitaker released the following statement:

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 medtech industry are playing a major role in improving patients’ lives through innovative care, reduced healthcare costs, and improved patient outcomes.

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.