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.
Regulatory Affairs
Learn more about our Regulatory Affairs work.
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…
i-GENTIC AI Expands GENIE to Enforce Full FDA Compliance Lifecycle for Life Sciences
PALO ALTO, CA, UNITED STATES, May 4, 2026 / EINPresswire.com / — Biopharma and medtech companies face a years-long process to get their products approved. Drug and device makers navigate a full…
A Policy Win for Maternal Health Innovation Through FDA–CMS Collaboration
The United States faces a maternal health crisis demanding urgent action. The U.S. has the worst maternal outcomes among high income nations. Our maternal mortality rates far exceed peer countries’,…
Compliance Considerations in an Active Deals Market for Medtech
Join PwC to explore how compliance leaders can proactively support deal activity across the transaction lifecycle.
AdvaMed® Cybersecurity Summit
Join cyber experts for the 2026 Cybersecurity Summit to address the latest industry issues and FDA requirements.
Carbon Medical Technologies’ InjecSURE® Injection System Receives FDA 510(k) Clearance, Expanding CMT’s Portfolio of Urology Delivery Solutions
Saint Paul, MN – April 15, 2026. Carbon Medical Technologies, Inc. (CMT), a manufacturer of implantable medical devices and delivery systems utilizing proprietary technologies, is pleased to announce that its…