Coding, Coverage and Reimbursement

NAPLES, Fla., Dec. 4, 2025 – Catalyst OrthoScience Inc. (“Catalyst”), a private medical technology company redefining shoulder arthroplasty through simplified, surgeon-focused innovation, today announced that its Catalyst Fracture Shoulder System has received FDA 510(k) clearance for additional indications that now include anatomic (total or hemi) shoulder procedures, giving surgeons flexibility to treat complex proximal humeral fractures (PHFs) with a single, streamlined platform for both anatomic and reverse replacements. In anatomic indications, the Catalyst Fracture System utilizes Catalyst’s ellipsoid head design, shown to better restore natural anatomy compared to traditional spherical head designs on the market today.

MINNEAPOLIS (Dec. 2, 2025) – Francis Medical, Inc., a privately-held medical device company developing the breakthrough Vanquish® Water Vapor Ablation System for the management of prostate cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for use of the Vanquish System for prostate tissue ablation. FDA clearance was supported by positive 12-month follow-up data on the first 110 patients enrolled in the company’s ongoing VAPOR 2 clinical study. The clearance marks a critical milestone for the company and enables a commercial launch of the Vanquish System.

WASHINGTON — AdvaMed, the medtech association, the world’s largest trade association representing medtech innovators, today released the following statement on the U.S. Centers for Medicare & Medicaid Services’ (CMS) release of its 2026 Home Health Prospective Payment System final rule:

WASHINGTON – AdvaMed, the Medtech Association, today commended Representatives John Joyce, M.D. (R-PA), Beth Van Duyne (R-TX), Jay Obernolte (R-CA), Brad Schneider (D-IL), Scott Peters (D-CA) and Angie Craig (D-MN) for introducing the Health Tech Investment Act (H.R. 6197), bipartisan legislation that seeks to improve health outcomes for Medicare patients through creation of a clear and consistent reimbursement pathway for a subset of the most innovative U.S. Food and Drug Administration-authorized artificial intelligence (AI)-enabled medical devices that provide more information than the clinician would have otherwise.

Imagine walking just 10 yards from your front door to the mailbox and becoming so winded, you feel like you might faint. Or imagine your heart beating so chaotically that its chambers don’t empty blood properly, creating clots that could lead to a stroke, yet you have zero symptoms and no idea you’re at risk.

WASHINGTON—AdvaMed, the Medtech Association, is pleased to announce Charles Fleischman as the first-ever recipient of the AdvaMedDx Lifetime of Leadership & Service Award. 

As patient advocates, we’ve witnessed countless stories of hope deferred and lives put on hold while Medicare beneficiaries wait several years for access to breakthrough medical technologies that the FDA has already deemed safe and effective. This unacceptable delay between innovation and access must end. Innovation does not benefit patients without coverage.

WASHINGTON—AdvaMed, the world’s largest trade association representing medtech innovators, today welcomed a letter from U.S. Senators Susan Collins (R-Maine) and Jeanne Shaheen (D-N.H.), co-chairs of the Senate Diabetes Caucus, and U.S. Representatives Diana DeGette (D-Colo.-01) and Gus Bilirakis (R-Fla.-12), co-chairs of the U.S. House Diabetes Caucus, to Centers for Medicare and Medicaid Services (CMS) Administrator Mehmet Oz urging the agency not to finalize a proposal the lawmakers warned could reduce and complicate patient access to continuous glucose monitors (CGMs) and durable insulin pumps.