AdvaMedDx® VALID Act Webinar

April 25, 2025 – Carbon Medical Technologies, Inc. (CMT), a manufacturer of pyrolytic carbon-coated medical devices used in biopsy procedures, for radiation therapy, and to treat stress urinary incontinence, is proud to announce that our BiomarC Tissue Marker System has successfully achieved certification under the European Union Medical Device Regulation (EU MDR 2017/745).

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).

AdvaMed®’s medtech priorities for the 119th Congress highlight opportunities to address the most important issues facing patients and the medical technology industry today.

AdvaMed®’s medtech priorities for the 119th Congress highlight opportunities to address the most important issues facing patients and the medical technology industry today.

One of healthcare’s most extensive and rapidly expanding market segments, Pointof-Care (POC) and at-home rapid diagnostic testing, has become an ever-increasing crucial topic in the medical world since COVID-19 was first declared a pandemic.

Today, Zach Rothstein, Executive Director of AdvaMedDx®, testified before the House Energy and Commerce Committee, Subcommittee on Health during a hearing on diagnostic test regulation and FDA’s proposed laboratory developed test (LDT) rule.