AdvaMed®
  • Our Work
    • Key Issues
    • Policy Areas
    • Sectors
    • Emerging Policy & Tariff Response Center
  • Industry Updates
    • Reports and Insights
    • Research & Policy Papers
    • Medtech POV with Scott Whitaker
    • Medtech POV Blog
    • Press Releases
  • Member Center
    • Committees & Working Groups
    • Resource Library
    • Medtech Career Center
  • Join
  • Events & Education
    • All Events & Education
    • In Person
    • Online
Login

Regulatory Affairs

Learn more about our Regulatory Affairs work.

Female doctor and assistant provide expert care during a follow-up health examination for a male patient.
Online

Shifting Customer Engagement Models in Diagnostics: Winning in a Rapidly Evolving Market

September 29, 2026
2:00 PM - 3:00 PM

Join Deloitte in this discussion examining how rising consumer expectations, new technology entrants, and evolving provider roles are reshaping how diagnostics manufacturers engage their customers.

Doctors use AI technology to diagnose, care for, and increase the accuracy of treatment for patients in the future. medical research
Online

Reimagining the Cost of Quality: The Agentic AI Opportunity for MedTech

September 30, 2026 10:00AM - 11:00AM ET

Join HCLTech in this discussion about practical use cases and strategies to scale AI-driven quality operations while maintaining compliance and enabling greater innovation.

The dome of the United States Capitol building with an American flag waving beside it, set against a partly cloudy blue sky
Coverage & Payment / Health Access / Regulatory Affairs

AdvaMed Welcomes Expiration of Moratorium on New Medicare Durable Medical Equipment Suppliers  

WASHINGTON—Scott Whitaker, president and CEO of AdvaMed, the medtech association, today welcomed the expiration of the moratorium on Medicare acceptance of Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) suppliers.…

Diagnostics / Medical Imaging / Regulatory Affairs

Cubresa Announces FDA 510(k) Clearance for the Cubresa BrainPET™ Scanner, Opening New Frontier in Clinical Brain Imaging

WINNIPEG, MANITOBA, CANADA, August 20, 2026 /EINPresswire.com/ — Cubresa Inc., a global leader in clinical and preclinical molecular imaging technologies, today announced that it has received FDA 510(k) clearance from the U.S.…

Diagnostics / Digital Health / Government & Legislative Affairs / Regulatory Affairs

AdvaMed Statement on the Nomination of Dr. Heidi Overton as FDA Commissioner

WASHINGTON—Scott Whitaker, president and CEO of AdvaMed, the medtech association, made the following comment on President Trump’s nomination of Dr. Heidi Overton to serve as FDA commissioner. 

Online

Software as a Medical Device: From Regulatory Strategy to Market Readiness

September 16, 2026
12:00 PM - 1:00 PM

Join MIDI as they provide a practical framework for developing SaMD products with regulatory requirements built into the development process.

Online

From Data Chaos to Trusted AI in MedTech:
Data Quality, Knowledge Graphs & Semantic Layers That Make It Possible

September 10, 2026
12:00 PM - 1:00 PM

Join Genpact as they provide a practical framework for connecting, governing, and activating service data – and a clear roadmap for scaling AI from pilot to confident business outcomes.

Health Access / Regulatory Affairs / Supply Chain

MedSource Labs Launches ClearSafe Comfort® Closed System, Rounding Out Its Full Line of Peripheral IV Catheters

Chanhassen, MN — MedSource Labs today announced the launch of the ClearSafe Comfort® Closed System, the first slide-activated safety peripheral IV catheter (PIVC) with an integrated extension set to receive…

Online

Quality and Regulatory at the Speed of AI: Moving Faster Without Losing Trust

September 24, 2026
12:00 PM - 1:00 PM

Join Suntra MedTech as they explore how AI is beginning to reshape the work of Quality and Regulatory—and what must not change.

Online

False Claims Act Risks and Enforcement Priorities for the Med Tech Industry

October 7, 2026
12:00 PM - 1:00 PM

Join Akin Gump as they provide actionable takeaways to minimize compliance risks and position organizations for effective and credible responses when FCA investigations arise.

  • 1
  • 2
  • …
  • 16
  • Next
AdvaMed®

Stay up to date with AdvaMed®.

Subscribe for Updates
  • Join
  • Member Center OLD
  • Industry Updates
  • Contact
  • FAQs
  • Events & Education
  • Careers
  • The Story of Medtech
  • The MedTech Conference
  • Because Every Moment Matters 

Copyright 2026 AdvaMed®

  • Sitemap
  • Terms of Use
  • Privacy Policy
  • Accessibility Statement
  • 中文
  • youtube
  • linkedin
  • facebook
  • X
  • medium
  • instagram

Menu

  • Our Work
    • Key Issues
    • Policy Areas
    • Sectors
    • Emerging Policy & Tariff Response Center
  • Industry Updates
    • Reports and Insights
    • Research & Policy Papers
    • Medtech POV with Scott Whitaker
    • Medtech POV Blog
    • Press Releases
  • Member Center
    • Committees & Working Groups
    • Resource Library
    • Medtech Career Center
  • Join
  • Events & Education
    • All Events & Education
    • In Person
    • Online
  • Login
  • About AdvaMed®
    • Our Leadership
    • Initiatives
    • Jobs at AdvaMed®
    • Contact Us
  • Membership & Join
    • Membership Directory
    • Associate Membership Directory
    • Membership Application
    • Awards
  • Medical Device Industry Facts
    • Safety & Quality
    • Job Creation
  • AdvaMed Accel®
    • Accel Member Directory
    • Partnerships and Opportunities – ARCHIVE
  • AdvaMedDx®
    • AdvaMedDx® Members
    • AdvaMedDx® Resources
    • Join AdvaMed®DX
  • AdvaMed® Digital Health Tech™
    • AdvaMed® Digital Health Tech™ Members
  • AdvaMed® Medical Imaging™
    • AdvaMed® Imaging® Members

Search