The Medical Innovation Agenda for the 119th Congress
AdvaMed®’s medtech priorities for the 119th Congress highlight opportunities to address the most important issues facing patients and the medical technology industry today.
Regulatory Affairs
Learn more about our Regulatory Affairs work.
AdvaMed®’s Medical Innovation Agenda for the 119th Congress
AdvaMed®’s medtech priorities for the 119th Congress highlight opportunities to address the most important issues facing patients and the medical technology industry today.
Connected Medical Devices
This white paper, “Connected Medical Devices”, explores the transformative impact of integrating Bluetooth Low Energy (BLE), mobile apps, cloud platforms, and AI/ML into medical devices. It highlights the benefits of…
Medical Device Submissions Workshops – Premarket Approval (PMA)
Our in-depth device submissions workshops will provide real-world case studies, tips and best practices directly from industry experts.
Medical Device Submissions Workshops – Investigational Device Exemption (IDE)
Our in-depth device submissions workshops will provide real-world case studies, tips and best practices directly from FDA and industry experts.
China Regulatory Workshop
Get the latest on new policy updates and guidance for the clinical evaluation of medical devices.
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…