Artificial Intelligence in Medical Technology Myths and Facts
Artificial intelligence (AI) and its subset, machine learning (ML), are expanding in multiple applications, including medical technology. Outlining the facts and dispelling myths will inform policymaking to avoid overlap with current regulations and preserve the broad capacity of innovation to help patients.
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News / Artificial Intelligence (AI) / Coverage & Payment / Diagnostics / Digital Health / Government & Legislative Affairs / Medical Imaging / Orthopedic / Regulatory Affairs / Small Business
Mick Farrell, Chairman and CEO of Resmed, Named Chair of AdvaMed Board of Directors
December 11, 2025
WASHINGTON, D.C.—AdvaMed, the Medtech Association, today announced Michael “Mick” Farrell, chairman and CEO of Resmed Inc. (NYSE: RMD, ASX: RMD), the leading health technology company focused on sleep, breathing, and care delivered in the home, will be the next chair of the AdvaMed Board of Directors. Farrell will serve a two-year term beginning in January 2026.
Event / Regulatory Affairs
Medical Device Submissions Workshop Series: Investigational Device Exemption (IDE)
8:30 am – 5:15 pm ET
February 25, 2026
Our in-depth device submissions workshops will provide real-world case studies, tips and best practices directly from FDA and industry experts.
Event / Regulatory Affairs
Medical Device Submissions Series: Premarket Approval (PMA) Workshop
8:30 am – 4:30 pm ET
February 26-27, 2026
Learn key PMA Submissions strategies to build a strong submissions, align with FDA expectations, and reduce delays.
Event / Regulatory Affairs
Medical Device Submissions Series: 510(k) & De Novo Workshop
Now available to purchase!
Join industry leaders for the in-depth 510(k) & De Novo Workshop for real-world case studies, submissions tips and best practices.
News / Government & Legislative Affairs / Health Access / Regulatory Affairs
AdvaMed Urges CMS to Protect Patient Access to Critical Medical Equipment
November 30, 2025
WASHINGTON — AdvaMed, the medtech association, the world’s largest trade association representing medtech innovators, today released the following statement on the U.S. Centers for Medicare & Medicaid Services’ (CMS) release of its 2026 Home Health Prospective Payment System final rule:
Event / Regulatory Affairs
QMSR Transition: Legal and Audit Perspectives
December 9, 2025
11:00 AM – 12:00 PM
Join Hogan Lovells experts to learn how the FDA is set to reshape the medical device regulatory landscape with the introduction of the QMSR.
News / Digital Health / Regulatory Affairs
AdvaMed Releases Technical Performance and Safety Bulletin on “Remote Device Operations: Common Challenges and Mitigation Strategies”
October 2, 2025
WASHINGTON, D.C. – AdvaMed, the Medtech Association, recently published a technical performance and safety bulletin titled, “Remote Device Operations: Common Challenges and Mitigation Strategies” to help health care providers, device manufacturers, and IT teams navigate the complex landscape of remotely managing medical devices.
News / Government & Legislative Affairs / Regulatory Affairs
CDRH Director Tarver, Fellow FDA Leaders to Speak, Take Questions at The MedTech Conference
September 8, 2025
WASHINGTON, D.C.—AdvaMed, the medtech association, today announced a town hall featuring FDA Center for Devices and Radiological Health (CDRH) Director Michelle Tarver and fellow CDRH senior leaders at The MedTech Conference hosted by AdvaMed in San Diego in October. The town hall participants will update the audience on the center’s strategic direction and priorities and take questions.