Phase I: Disparities in Access to Advanced Medical Procedures in the Medicare Population

WASHINGTON, D.C.—AdvaMed, the Medtech Association, today recommended refinements the Centers for Medicare & Medicaid Services (CMS) could make to help its proposed Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway deliver more timely access to breakthrough medtech for Medicare beneficiaries.

AUSTIN, Texas – October 8, 2026 – Paradromics Inc., a neurotechnology company developing high-data-rate brain-computer interfaces (BCIs) to restore and enhance human capabilities, today announced that its brain-computer interface has demonstrated more than four years of stable neural recording and decoding performance.

Aliso Viejo, Calif. – Terumo Neuro today announced that it has signed an agreement to acquire Arsenal Medical Inc., a privately held, clinical-stage biomaterials company developing NeoCast™, an investigational next-generation liquid embolic technology for the treatment of chronic subdural hematoma (cSDH). Upon completion, the proposed acquisition would expand Terumo Neuro’s liquid embolic portfolio, advance its strategy to bring differentiated neurovascular technologies to physicians and patients, and support its continued focus on innovations to preserve and restore brain health.

SAN ANTONIO/SALT LAKE CITY, UT — Freyya Inc., a pioneer in women’s pelvic health technology, today announced the oversubscribed close of its pre-seed financing. The financing provides the capital to advance Freyya’s technology through its next regulatory milestones and continue building the foundation for commercialization.

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.

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.

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. 

 “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.