Advancing Improved Healthcare Access Through MedTech

AdvaMed Digital Health Tech division member companies include world leaders in developing AI-enabled solutions to improve health and care, from diagnosis to treatment, clinical decision support, and wearables to wellness. “The Insight Series: AI & Digital Health” will feature company experts, answering pressing questions to inform policymakers and the public about how AI and digital health are transforming care and delivery. Our inaugural entry is a conversation between Melissa Cha of Amazon and Taha Kass-Hout of GE HealthCare.

In a new video developed in partnership with Patients Rising, AdvaMed’s Peter Weems, Vice President of Imaging Government Affairs and Policy Strategy, explains why the Health Tech Investment Act is critical to expanding patient access to FDA-authorized AI-enabled medical devices.

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.