Coding, Coverage and Reimbursement
Bridging the Gaps in Women’s Health Access and Reimbursement
This white paper, commissioned byAdvaMed® and conducted by Health Management Associates (HMA), explores persistent disparities in women’s health research, innovation, and access to care.
Through an analysis of research funding, insurance claims data, Medicare policies, and coding structures—focused on pelvic health, maternity care, and mental health—the report uncovers areas where reimbursement and access may lag for women.
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Emanate Receives FDA 510(k) Clearance for Perio PODS™, the First FDA-Cleared At-Home Periodontal Wound Dressing Indicated Following Non-Surgical Periodontal Procedures
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NEW YORK, Sept. 17, 2026 (GLOBE NEWSWIRE) — Emanate Biomedical, Inc., a medical technology company creating a new category of clinician-directed at-home oral care, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance for Perio PODS™, a periodontal wound dressing consisting of single-use, patient-matched dental trays preloaded with engineered hydrogel.
Health Access
Patient Access to Breakthrough Medical Devices
Patients should not have to wait years for Medicare coverage of procedures using breakthrough medical technologies the FDA has already authorized for marketing after determining they meet applicable safety and effectiveness standards.
News / Coverage & Payment / Health Access / Regulatory Affairs
AdvaMed Welcomes Expiration of Moratorium on New Medicare Durable Medical Equipment Suppliers
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WASHINGTON—Scott Whitaker, president and CEO of AdvaMed, the medtech association, today welcomed the expiration of the moratorium on Medicare acceptance of Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) suppliers. He made the following comment on the expiration.
Blog / Artificial Intelligence (AI) / Digital Health / Health Access
The Insight Series: AI & Digital Health with Kelly Huang
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“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. This edition features Kelly Huang, CEO of Elucid, an AI medical technology company focused on providing physicians with a more precise, non-invasive view of atherosclerosis to drive patient-specific cardiovascular care.
News / Health Access / Regulatory Affairs / Supply Chain
MedSource Labs Launches ClearSafe Comfort® Closed System, Rounding Out Its Full Line of Peripheral IV Catheters
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Chanhassen, MN — MedSource Labs today announced the launch of the ClearSafe Comfort® Closed System, the first slide-activated safety peripheral IV catheter (PIVC) with an integrated extension set to receive FDA 510(k) clearance.
Blog / Global & Trade / Health Access
Memory Chip Shortages: Implications for Medtech Innovation and Patient Care
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Global memory chip shortages are creating growing challenges for the medical technology sector. These disruptions could affect timely patient care and innovation, underscoring the need for collaboration with memory chip suppliers and federal partners to safeguard access to essential medical technologies.
Resource / Coverage & Payment / Regulatory Affairs
AdvaMed® Comments on FDA-2016-D-1307 Communications with Payors
August 7, 2026
AdvaMed’s recent submission to the Food and Drug Administration (FDA) provides comments on the Agency’s revised draft guidance governing communications between drug and device manufacturers and payors, formulary committees, and similar entities.
Event / Health Access
Investing in Women’s Health Products and Companies
September 24, 2026
1:00 PM – 2:00 PM
Examine the evolving investment landscape, share lessons learned, and discuss strategies that help women’s health companies attract investment and drive growth.