The U.S. Food and Drug Administration (FDA) has now granted Breakthrough Device designation to more than 1200 medical devices.
According to the latest data available from the agency, the FDA’s Center for Devices and Radiological Health (CDRH) and its Center for Biologics Evaluation and Research (CBER) have granted 1246 Breakthrough Device designations through December 31, 2025. Fiscal year 2025 (October 1, 2024, through September 30, 2025) saw 164 designations, consistent with the annual numbers for fiscal years 2022, 2023, and 2024.
Fiscal year 2021, which corresponded with the global COVID-19 outbreak, saw a record 206 device clearances under the Breakthrough Device Program.
Initiated in 2015, the FDA’s Breakthrough Devices Program is intended to make innovative and advanced medical devices more readily accessible to patients and healthcare providers. The Program facilitates the more efficient assessment and review of devices for premarket approval, including 510(k) clearance and De Novo marketing authorization, without compromising the FDA’s standards for device safety and effectiveness.
More information about the FDA’s Breakthrough Devices Program is available at https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program?utm_medium=email&utm_source=govdelivery#metrics.