The emergence of artificial intelligence (AI) and machine learning (ML) can be seen across multiple industries, transforming everything from healthcare to transportation. Artificial intelligence has been in the spotlight recently, but it is not a new concept to the Food and Drug Administration (FDA) or the medtech industry. AI advancements in the medtech industry are playing a major role in improving patients’ lives through innovative care, reduced healthcare costs, and improved patient outcomes.
Related Reading
Blog / Coverage & Payment / Diagnostics / Global & Trade / Government & Legislative Affairs / Regulatory Affairs / Small Business
AdvaMed®’s Medical Innovation Agenda for the 119th Congress
March 28, 2025
AdvaMed®’s medtech priorities for the 119th Congress highlight opportunities to address the most important issues facing patients and the medical technology industry today.
Event / Coverage & Payment / Regulatory Affairs
Impact of FDA Changes on Medtech Research
April 3, 2025
11:30 AM – 12:30 PM
On April 3, NAMSA hosts a webinar with Dr. Jeff Shuren, former FDA CDRH Director, discussing FDA changes impacting Medtech development. RSVP today.
Resource / Compliance / Global & Trade / Regulatory Affairs
State of the Nation 2025: Global Medical Device Recall Index Report
March 27, 2025
Download Sedgwick’s Global Medical Device Recall Report for key insights on compliance, regulations, and global recall trends. Members only.
Event / Compliance / Coverage & Payment / Regulatory Affairs
Richardson Waiver Repeal: What it Means for Medtech
April 22, 2025
1:00 PM – 2:00 PM
Sidley Austin, joined by HPA, will lead a program examining the impact of HHS repealing the so-called “Richardson Waiver”, including its history, how it could impact the activities of the U.S. Department of Health and Humans Services (HHS), what it all means for medtech and its patients.
News / Government & Legislative Affairs / Regulatory Affairs
AdvaMed® Congratulates Dr. Makary on his Confirmation as FDA Commissioner
March 26, 2025
Today, AdvaMed®, the Medtech Association, the largest global trade organization representing medical technology companies, released its “Medical Innovation Agenda for the 119th Congress.” These policy priorities would advance AdvaMed®’s goal to usher in a new era of health care innovation on behalf of all American patients, promoting access to the latest lifesaving technologies.
Resource / Coverage & Payment / Diagnostics / Global & Trade / Government & Legislative Affairs / Health Equity / Legal / Regulatory Affairs / Small Business
The Medical Innovation Agenda for the 119th Congress
March 13, 2025
AdvaMed®’s medtech priorities for the 119th Congress highlight opportunities to address the most important issues facing patients and the medical technology industry today.
Resource / Digital Health / Regulatory Affairs
Connected Medical Devices
February 25, 2025
This white paper, “Connected Medical Devices”, explores the transformative impact of integrating Bluetooth Low Energy (BLE), mobile apps, cloud platforms, and AI/ML into medical devices. It highlights the benefits of real-time data exchange, remote monitoring, and enhanced clinical decision-making while addressing challenges such as security, FDA compliance, and data management. The document includes a case study on an implantable neural stimulator, outlines key design considerations, and discusses mobile and cloud-based platforms for connected healthcare solutions. Developed by Sunrise Labs, the paper provides insights into engineering best practices for next-generation medical devices.
Event / Regulatory Affairs
Medical Device Submissions Workshops – Premarket Approval (PMA)
8:30 am – 4:30 pm ET
February 6-7, 2025
Our in-depth device submissions workshops will provide real-world case studies, tips and best practices directly from industry experts.