Market of First Launch for High-Risk Therapeutic Medical Devices

Kushal T Kadakia; Christina Lalani; Daniel B Kramer; Hibiki Orui; Robert W Yeh

doi:10.1001/jamanetworkopen.2024.49298

Market of First Launch for High-Risk Therapeutic Medical Devices

JAMA Netw Open. 2024 Dec 2;7(12):e2449298. doi: 10.1001/jamanetworkopen.2024.49298.

Authors

Kushal T Kadakia¹, Christina Lalani², Daniel B Kramer³, Hibiki Orui³, Robert W Yeh³

Affiliations

¹ Harvard Medical School, Boston, Massachusetts.
² Division of Cardiology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.
³ Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology, Division of Cardiology, Beth Israel Deaconess Medical Center, Boston, Massachusetts.

No abstract available

Plain language summary

This cross-sectional study examines the marketing history of high-risk medical devices launched first in the international market or the US, including specialty, time from US Food and Drug Administration Review to launch, and recall history.