Principles for Artificial Intelligence in Medical Technology
This document provides the medical device industry’s foundational principles for artificial intelligence in medical technology. These principles will guide further innovations, policymaking, and regulations in AI-enabled medical technology.
Related Reading
News / Regulatory Affairs / Small Business
Carbon Medical Technologies’ InjecSURE® Injection System Receives FDA 510(k) Clearance, Expanding CMT’s Portfolio of Urology Delivery Solutions
April 16, 2026
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 InjecSURE® Injection System has received clearance from the U.S. Food and Drug Administration (FDA) through the 510(k) pathway. This milestone marks the introduction of a new accessory system designed to support the delivery of syringe-based injectable materials into urethral tissues during cystoscopic procedures.
Resource / Regulatory Affairs
AdvaMed® Comment Letter to FDA: Exemptions from Premarket Notification Requirements for Class II Devices
April 15, 2026
AdvaMed’s® comments on FDA’s 510(k) exemption framework for Class II devices and its impact on innovation and patient access.
Event / Regulatory Affairs
Pulse on MedTech: How the Industry is Reigniting Growth and Expanding Markets
April 30, 2026
11:00 AM – 12:00 PM
Join Ernst & Young LLP in this session that explores key trends shaping the sector.
Event / Regulatory Affairs
The UPC – Three Years In Cross-Border Medtech Patent Strategy in the New European Landscape
April 28, 2026
1:00 PM – 2:00 PM
Join McDermott Will & Schulte Law in this session that will explore practical, cross-border patent litigation strategies for navigating the UPC system specifically for the medtech sector.
Event / Regulatory Affairs
The State of the MedTech Customer Base
May 7, 2026
1:00 PM – 2:00 PM
Join L.E.K. Consulting to explore hospital financial health, purchasing behavior, and strategic priorities, and what they mean for medtech growth, partnerships, and innovation.
Event / Regulatory Affairs
Beyond the Silo: Why Fragmentation Is MedTech’s Biggest Threat
May 6, 2026
12:00 PM – 1:00 PM
Discover how Salesforce is helping medtech organizations improve margins and scale with AI powered, connected enterprise platforms.
Event / Regulatory Affairs
FDA For-Cause Inspections Targeting Medical Device Manufacturers: Navigating the Process, Mitigating Risks
April 13, 2026
10:00 AM – 11:00 AM
Join Hogan Lovells in this webinar will examine FDA for-cause inspections as they relate to medical device manufacturers.
Resource / Artificial Intelligence (AI) / Coverage & Payment / Digital Health / Regulatory Affairs
AdvaMed® Comment Letter to ASTP/ONC: Accelerating AI Adoption in Clinical Care
February 24, 2026
AdvaMed’s® Comment Letter to ASTP/ONC, outlines concrete policy reforms across FDA oversight, CMS payment pathways, and HIPAA data-sharing rules to accelerate patient access to AI-enabled medical technologies. As AI-enabled medical devices transform patient care, outdated regulatory, coverage, and privacy frameworks are slowing the pace of adoption.
