Therapeutic Benefit Ratings for FDA Breakthrough-Designated Devices
This cross-sectional study evaluates the level and characteristics of health technology assessment ratings outside the US for medical devices granted breakthrough designations by the FDA.
Authors
- Sanket S. Dhruva (ORCID: https://orcid.org/0000-0003-0674-2032)
- Christine M. Swoboda (ORCID: https://orcid.org/0000-0002-2085-2126)
- James Francis Burke (ORCID: https://orcid.org/0000-0002-2296-1588)
- Kushal T. Kadakia (ORCID: https://orcid.org/0000-0002-9539-7682)
- Osman Moneer (ORCID: https://orcid.org/0000-0003-3191-8028)
- Vinay K. Rathi
- Joseph S. Ross
- Harlan M. Krumholz
Institutions
- Yale New Haven Hospital (US)
- University of California, San Francisco (US)
- Yale University (US)
- Massachusetts General Hospital (US)
- Yale New Haven Health System (US)
- The Ohio State University (US)
- Stanford University (US)
Publication Details
- Journal
- JAMA Surgery
- Published
- 2026-02-25
- DOI
- https://doi.org/10.1001/jamasurg.2025.6859
- Primary Topic
- Health Systems, Economic Evaluations, Quality of Life
- Type
- article
- Field-Weighted Citation Impact
- 0.00