MY01 Continuous Compartmental Pressure Monitor granted Breakthrough Device Designation from the FDA

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.

DeChane Dorsey, Executive Director of AdvaMed Accel and a  leading voice for early-stage innovation, to explore why this year’s programming is especially critical for small companies and entrepreneurs.

WASHINGTON, D.C.—Scott Whitaker, president and CEO of AdvaMed, the medtech association, made the following comment on the collaboration between Revival Healthcare Capital and Olympus Corporation to co-found Swan EndoSurgical, Inc. to develop a robotics platform to provide earlier, safer, and more effective treatment of lesions or tumors in the gastrointestinal tract relative to current therapeutic options. 

WASHINGTON—AdvaMed, the Medtech Association, welcomed introduction of the bipartisan Access to Prescription Digital Therapeutics Act of 2025 (S. 1702/H.R. 3288) by U.S. Sens. Shelley Moore Capito (R-W.Va.) and Jeanne Shaheen (D-N.H.) and U.S. Reps. Kevin Hern (R-Okla.) and Mike Thompson (D-Calif.). The bill provides for Medicare and Medicaid coverage of evidence-based software applications used to prevent, manage, or treat medical conditions.

EPAM recently published a case study highlighting the rise of composable commerce solutions to enable B2B processes in the healthcare industry. This piece focuses on the experience of diagnostics company, Cepheid – a part of Danaher Corporation.

AdvaMed®’s medtech priorities for the 119th Congress highlight opportunities to address the most important issues facing patients and the medical technology industry today.

AdvaMed®’s medtech priorities for the 119th Congress highlight opportunities to address the most important issues facing patients and the medical technology industry today.