The number of breakthrough device designations granted by the FDA has seen a gradual increase and peaked in recent years, according to new data.
The breakthrough device designation provides sped-up processes for development, assessment and review for clearance for selected products.
Four things to know:
1. The number of breakthrough device designations has jumped from 11 in 2015 to 80 in the first quarter of 2026.
2. Breakthrough device designations began reaching triple digits in 2019 (110) and saw a peak in 2021 (206). From 2022 through 2025 the number of breakthrough designations ranged from 145 to 166.
3. Orthopedic devices are the third-most common to earn breakthrough device designations making up 176 of all products earning the nod. Cardiology (260) and Neurology (200) topped the list.
4. Spine devices that earned breakthrough designation over the years include the Limiflex dynamic sagittal tether, Tops spine system and aprevo lumbar interbody fusion system.
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