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FDA premarket approvals (PMAs) are trending ahead of last year’s numbers, but timing is substantially longer compared to last year, according to a new report from Ryan Zimmerman, a medtech analyst at BTIG.
In his mid-year check-up of FDA’s medical technology databases, Zimmerman noted that FDA approvals (PMAs) are taking, on average, about 599 days this year compared to about 402 days in 2025.
Other stats the analyst noted include:
FDA 510(k) clearances are trending up about 2.5% year-over-year as 1,669 medical devices have been cleared through June 2026. Assuming about 1,570 (14-year average) are cleared in the second half of the year, the implied number of clearances is expected to be about 3,239 (2.0% year-over-year).
The average days to a 510(k) submission decision is at about 155.9 days through June 2026, about a 5.2% increase from the 2025 submission decision time frame of about 148.2 days.
There have been 23 original PMAs approved through June 2026, up 10 from this time last year. Assuming 28 PMAs are approved in the second half of the year (last year’s second-half run rate), Zimmerman estimates that about 51 PMAs will be approved this year, above last year’s levels.
The average number of days to PMA approval is up to about 598.5 days compared to 2025’s time frame of about 401.7 days. However, the analyst noted there are a few outliers that drove this timeframe higher, which finally achieved approval in the first half of 2026. Excluding these three outliers, the time to approval drops to about 339 days, Zimmerman reported.
The panel track approval data through June 2026 imply about a 16.7% year-over-year increase, as FDA data indicate 16 approvals in the first half of the year, and if 19 are approved in the second half of the year (last year’s second-half run rate), Zimmerman said that implies 35 panel track approvals in 2026.
The average days to panel track approval have increased to about 306.6 days through June 2026, which is a 6.5% increase from 2025 levels, the analyst reported.
Zimmerman reported that there have been 14 de novo classifications through June 2026, in-line with the number of approvals from this time last year (about 14). Assuming the second half run rate from 2025 of 13 de novo classifications holds constant, that would imply 27 de novo classifications in 2026.
Average days to de novo approval is about 341 through June 2026, which is about an 8.3% year-over-year increase from 2025 levels.
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From a volume perspective, the analyst noted that the approvals in the first half of 2026 suggest an acceleration across the various pathways despite the fact that timing is taking longer."Overall, we're encouraged by the absolute level of approvals within medical technology tracks, but we believe for many reading this, the timing to approval carries more importance in terms of the implications of capital runway and demand forecasting (especially for smaller companies bringing new technologies to market)," Zimmerman wrote.
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About the Author
Senior Editor, MD+DI, Informa Markets – Engineering
Amanda Pedersen is a veteran journalist and award-winning columnist with a passion for helping medical device professionals connect the dots between the medtech news of the day and the bigger picture. She has been covering the medtech industry since 2006.
Amanda's weekly op-ed, Pedersen's POV, was a 2023 Neal Awards Winner for "Best Commentary," a 2024 Neal Awards finalist for "Best Commentary," and a 2025 Neal Awards Winner for "Best Commentary."
Amanda Pedersen poses with her Jesse H. Neal Awards plaque after winning the "Best Commentary" category with Pedersen's POV
After 18 years of reporting on the medical device and diagnostics industry, Amanda has no fear of speaking truth to power. That's important in an industry in which over half of the top 100 companies report more than $1 billion in revenue. In her weekly Pedersen's POV opinion column, she isn't afraid to shine a light on industry leaders for bad behavior. Her insights spark conversation about what price is too high to pay for corporate success in medtech.
Amanda graduated from Northern Illinois University in 2003 with a B.A. in Communication. After a few years reporting for community newspapers, including the Galesburg Register Mail in Galesburg, IL, and the Marietta Daily Journal in Marietta, GA, Amanda spent 10 years covering the medical device industry for Medical Device Daily (now known as BioWorld MedTech). Amanda joined the editorial staff of MD+DI in December 2016.