Keeping Pace with Real-World Evidence: Evolving Software Regulations and the Growing Application of Artificial Intelligence

Washington, D.C.—AdvaMed, the Medtech Association, today released its “AI Policy Roadmap,” a detailed policy outline for Congress and the federal agencies with jurisdiction over medtech to consider in promoting the next era of artificial intelligence-enabled medical and digital health technologies to provide patients and clinicians transformative new tools to aid in diagnosis and treatment. 

BOSTON and NEW YORK, April 14, 2025 /PRNewswire/ — Satio and Nanowear have agreed to partner to advance patient-friendly, home-based diagnostic, and therapeutic care. This collaboration integrates Nanowear’s at-home AI-based nanotechnology biomarker diagnostic platform with Satio’s at-home blood draw diagnostics and drug delivery systems/patches: combining time synchronous, in vivo and in vitro diagnostics for precision therapeutics and individualized AI-based risk assessment.

WASHINGTON – AdvaMed, the Medtech Association, today commended Senators Mike Rounds (R-SD) and Martin Heinrich (D-NM) for introducing the Health Tech Investment Act (S. 1399). This landmark bipartisan legislation will establish a stable reimbursement pathway for medical devices authorized by the U.S. Food & Drug Administration (FDA) that rely on artificial intelligence (AI) and machine learning (ML), also known as Algorithm-Based Healthcare Services (ABHS).

Each year, L.E.K. surveys approximately 200 senior hospital executives and administrators to uncover key strategic priorities, trends, challenges, and opportunities in the healthcare industry. Join the L.E.K. Medtech team as we share these valuable insights and discuss what this means for MedTech companies.

The use of ePTFE in medical devices has enormous advantages, but getting it right requires deep expertise. Join us as we explore the benefits, risks, and mitigation strategies, along with innovative processing approaches that unlock its full potential.

EPAM recently published a case study highlighting the rise of composable commerce solutions to enable B2B processes in the healthcare industry. This piece focuses on the experience of diagnostics company, Cepheid – a part of Danaher Corporation.

Discover how AI is transforming medical technology with the AI Policy Roadmap. Learn how Congress can unleash even more innovation with targeted legislation. Download your copy today!

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.