The Widening AI Gap: Why AI-First MedTech Companies Are Pulling Ahead
Join Boston Consulting Group as they explore how medtech organizations are using AI to transform product development and accelerate innovation.
Regulatory Affairs
Learn more about our Regulatory Affairs work.
AdvaMed Welcomes Key Developments in MDUFA VI Process
WASHINGTON, D.C.—AdvaMed, the Medtech Association, today welcomed next steps in the Medical Device User Fee Amendments reauthorization process following clearance by the White House Office of Management and Budget of…
AdvaMed Statement on the Klomp Nomination
WASHINGTON—Scott Whitaker, president and CEO of AdvaMed, the largest trade association representing medtech innovators, posted his statement on LinkedIn regarding the nomination of Chris Klomp as deputy secretary of the…
Essential Tremor Treatment: A Sensible Solution, Possibly Driven Out of Reach
Millions of Americans have the neurological condition essential tremor. Often, that means their hand shakes so badly, they can’t hold a pen, fork, or glass of water. Every activity of…
China GMP and ISO 13485: A Side-by-Side Comparison
China GMP and ISO 13485: A Side-by-Side Comparison
Accelerating Medtech Innovation Through AI-Enabled Product Development
Join Kearney as they explore how medtech organizations are using AI to transform product development and accelerate innovation.
Accelerating ASC Transition and Medtech Commercial Model Imperatives
Explore ASC growth trends, buyer dynamics & go-to-market strategies for medtech manufacturers in this webinar with Alexander Group.
Clinical Evidence for IVD Medical Devices
AdvaMed’s feedback on the CEIVD draft outlines targeted recommendations to improve clarity in clinical evidence expectations for IVD devices, including more precise terminology, alignment with global frameworks, and clearer distinctions…
AdvaMed® Welcomes Senate Introduction of Bipartisan Medical Device Electronic Labeling Bill
Washington, D.C.—AdvaMed, the Medtech Association, the world’s biggest trade association representing medtech innovators, welcomed Senate introduction of the bipartisan Medical Device Electronic Labeling Act (S. 4519), which would allow medtech…
Bright Uro Receives FDA Clearance for Glean® Abdominal Sensor
IRVINE, Calif., May 7, 2026 /PRNewswire/ — Bright Uro, a medical device company with a mission to transform care for lower urinary tract dysfunction (LUTD) through innovations in urodynamics, today announced that the…