Coding, Coverage and Reimbursement

“The Insight Series: AI & Digital Health” features industry experts answering key questions to help inform policymakers and the public about how AI is shaping the future of care delivery. Our latest edition features Carlos Nunez, Chief Medical Officer at Resmed.

WASHINGTON—AdvaMed, the Medtech Association, the largest trade association representing medtech innovators, has long pressed for faster Medicare consideration of covering treatments using FDA-authorized breakthrough medtech. President and CEO Scott Whitaker made the following comment on a new initiative from FDA Commissioner Makary and CMS Administrator Oz on greater collaboration between the agencies to close the long gap — a median of nearly six years — between FDA authorization of breakthrough medtech and Medicare coverage. The new Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway would “expedite access to certain FDA-designated Class II and Class III Breakthrough Devices for people with Medicare,” according to FDA.

BERKELEY, Calif., April 21, 2026 — Gravitas Medical, Inc., a developer of advanced enteral feeding technologies, today announced the initiation of a prospective, multicenter clinical study evaluating its next-generation (Gen 2) smart feeding tube system in neonatal and infant patients. The Gravitas Entarik™ Feeding Tube System is FDA-cleared and has received Breakthrough Device Designation from the U.S. Food and Drug Administration. The study is being conducted at three leading institutions, including HCA Memorial Health Savannah.

The tax incentives in the One Big Beautiful Bill Act passed by Congress and signed into law by President Trump last year are a prime example of the public policies reinforcing the U.S. position as the global leader in medtech innovation. 

“The Insight Series: AI & Digital Health” features industry experts answering key questions to help inform policymakers and the public about how AI is shaping the future of care delivery. Our latest edition features Julia Strandberg, Executive Vice President, Chief Business Leader, Connected Care at Philips.

WASHINGTON—AdvaMed®, The Medtech Association®, today announced a strategic event partnership with Informa, the global events leader and owner of the LSX portfolio of life sciences conferences, to strengthen collaboration across leading medtech convenings in the United States, Europe, and Asia-Pacific.

WASHINGTON—AdvaMed® announced today that nominations for its 2025 Lifetime Achievement Award as well as the AdvaMedDx Lifetime of Leadership & Service Award and theAdvaMed® Imaging Röntgen Award are open through April 10. All three of these annual awards will be presented during The MedTech Conference, Oct.18-21, 2026, in Boston. 

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.