Dive Brief:
- The Food and Drug Administration’s breakthrough program has made a steady start to the 2026 financial year, granting designations at the same pace as in the two prior years.
- After years of growth that peaked in 2021, designations have settled at a lower rate in recent years. The agency awarded 164 to 166 designations per financial year three times from 2022 to 2025.
- The FDA is on course to grant a similar number of breakthrough designations in its 2026 financial year. After one quarter, the agency had awarded 42 designations, a pace that would result in 168 breakthrough statuses if maintained across the full financial year.
Dive Insight:
The FDA’s breakthrough program gives a special designation to devices that potentially provide a more effective treatment or diagnosis to life-threatening conditions. The program is intended to speed up patient access to certain devices.
Industry trade groups have advocated for speedier Medicare coverage of breakthrough devices. Dr. Mehmet Oz, administrator for the Centers for Medicare and Medicaid Services, said he supported speedier Medicare coverage for breakthrough devices during his confirmation hearing.
Medicare currently provides national coverage to up to five breakthrough devices per year. The medical device industry advocates for expansion of Medicare coverage to all breakthrough devices.
The FDA’s earlier update of breakthrough devices covered designations issued through June 30. At that time, the FDA had granted 136 designations over the first nine months of its financial year. The pace of new designations slowed slightly over the final three months of the financial year, resulting in the agency issuing 164 breakthrough statuses.
The total was close to the number of breakthrough statuses in 2022 and 2024, when the FDA issued 166 and 165 designations, respectively. The recent outliers are the pandemic-era peak of 206 in 2021 and the dip to 145 in 2023. Three months into the financial year, 2026 is tracking within the recent range.
In total, the FDA had issued 1,246 breakthrough device designations as of Dec. 31. The specialties with the most breakthrough designations were unchanged in the latest update, with the top three continuing to read cardiovascular, neurology and orthopedics.
Orthopedics was the most active area over the second half of calendar 2025. The FDA issued 13 breakthrough designations to devices in the therapeutic area. Gastroenterology and urology, which is fourth on the all-time list, was the second most active area with 11 new designations.
As well as awarding new designations, the FDA approved 25 breakthrough devices for use in the U.S. over the second half of calendar year 2025. As of Dec. 31, the FDA had granted marketing authorization to 185 breakthrough devices over the history of the program.
The recently authorized breakthrough devices include Edwards Lifesciences’ Sapien M3 transcatheter mitral valve replacement system. The FDA authorized the device for treating moderate to severe mitral regurgitation in December. Other breakthrough devices authorized in the second half of calendar 2025 include Roche’s Alzheimer’s disease tau test and Quest Diagnostics’ gene therapy eligibility test.
