Learn more about our Regulatory Affairs work.
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…
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…
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…
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…
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’,…
Join PwC to explore how compliance leaders can proactively support deal activity across the transaction lifecycle.
Join cyber experts for the 2026 Cybersecurity Summit to address the latest industry issues and FDA requirements.
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…
AdvaMed’s® comments on FDA’s 510(k) exemption framework for Class II devices and its impact on innovation and patient access.
Join Ernst & Young LLP in this session that explores key trends shaping the sector.