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 FDA and industry experts.
Regulatory Affairs
Learn more about our Regulatory Affairs work.
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.
Medical Device Submissions Workshops – 510(k) and De Novo
Our in-depth device submissions workshops will provide real-world case studies, tips and best practices directly from FDA and industry experts.
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…