FDA Reports Over 1,100 Breakthrough Device Designations Since 2015

The US Food and Drug Administration (FDA) has granted 1,176 breakthrough device designations since the program began in 2015, according to the agency’s latest update. The designation is reserved for devices that could significantly improve diagnosis or treatment of serious or life-threatening conditions.

In the 2025 fiscal year, which began last October, the FDA had issued 136 breakthrough designations as of June 30. This comes after the agency approved 165 devices in FY 2024, with most falling under cardiovascular, neurological, and orthopedic categories.

The update coincides with renewed lobbying by medical device manufacturers for broader Medicare coverage of breakthrough-designated products. Currently, Medicare can provide national coverage for up to five breakthrough devices per year soon after FDA authorization. Industry groups are pressing for coverage to extend to all designated devices.

Past efforts to fast-track coverage have faced setbacks. A CMS rule finalized under the Trump administration allowed four years of near-automatic coverage, but the Biden administration repealed it, citing concerns over limited clinical evidence.

23-08-2025