The FDA’s Breakthrough Devices Program is designed to accelerate development and review of devices that offer meaningful advances in care for serious or life-threatening conditions. With more than 1,200 devices designated since 2015, the program has become a central pathway for medtech innovation.
Here are six takeaways from the program’s trajectory through the end of 2025, according to the FDA:
1. The program is growing — and sustaining momentum.
Since its launch, 1,246 devices have received breakthrough designation. While designations peaked in 2021 at 206, the pace has remained steady, with 136 designations in 2025 alone. The program has evolved from a pilot effort into a core pathway for high-impact innovation.
2. Not just designation — authorizations are increasing.
As of December 2025, 185 devices that received breakthrough designation have gone on to earn FDA marketing authorization — a sign the program is not only accelerating development but also advancing patient access, the agency said.
3. Cardiology and neurology lead the way.
Breakthrough designations have been concentrated in several clinical areas:
- 243 in cardiovascular medicine
- 189 in neurology
- 161 in orthopedics
These specialties reflect strong clinical need, large patient populations and significant opportunity for technology-driven advances.
4. AI, diagnostics and digital health are increasingly represented.
Among devices that have received marketing authorization, several reflect software-first or AI-enabled technologies — including AI-assisted ECG tools, seizure monitoring systems and radiology triage algorithms. The breakthrough pathway is proving useful for advanced diagnostics as well as therapeutics, the agency said.
5. Multiple pathways to qualification.
To qualify, a device must treat or diagnose a life-threatening or irreversibly debilitating condition and meet at least one of four criteria, such as having no existing alternatives or offering a significant advantage over current options. Devices can originate from startups or established medtech firms and span implants, wearables and at-home diagnostics.
6. It’s not the only expedited pathway, but it’s the most established.
The Breakthrough Devices Program has become the FDA’s most visible expedited device pathway. Developers may also consider the Safer Technologies Program (SteP) for certain lower-risk conditions and the Total Product Life Cycle Advisory Program (TAP) for support from development through commercialization.
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