The FDA has approved more medical devices in the first half of 2026 than the same period a year ago despite “substantially longer” approval timelines, according to a recent BTIG analysis.
BTIG analyst Ryan Zimmerman said while the increase in approvals is promising, longer decision times may have financial implications for medical device developers.
“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 said in the report.
Original premarket approvals (PMAs) are trending ahead of 2025’s pace with 23 PMAs approved through June 2026, up 10 from this time last year.
The average time from submission to PMA approval increased to nearly 599 days, up 49% from 402 days in full year 2025.
If the trend continues, BTIG predicts about 51 devices will be approved in 2026, ahead of 2025 levels.
Related: Why smarter FDA pre-submissions matter more than ever
FDA data shows 510(k) approvals are trending 3% up year over year with 1,669 approvals through June 2026.
The average 510(k) decision time increased to just over 155 days through June, up 5% from 148 days in full year 2025.
If the trend continues, BTIG predicts about 3,239 510(k) approvals for 2026, up 2% from the year before.
Panel-track approval data through June 2026 shows a 17% year-over-year increase in approvals, with 16 approvals this year so far.
The average panel-track days to approval increased to just over 306 days, up 7% from full year 2025.
BTIG predicts 35 panel-track approvals in 2026 if the trend continues.
According to the data, the FDA awarded 14 de novo classifications through June 2026, the same number of approvals as at this time last year.
Despite the consistent number of classifications, the average timeline for those novel devices increased to 341 days, up 8.3% from full year 2025.
Related: Device developers must take action as experts leave FDA
The longer review timelines could be a result of job cuts at the FDA under the Trump administration and U.S. Department of Health & Human Services Secretary Robert F. Kennedy Jr.
In its annual report for the year ended in October 2025, the FDA’s Center for Devices and Radiological Health (CDRH) acknowledged “resource challenges” but said it was “on track to meet key targets for review timelines across device types, ensuring that innovators receive clear and consistent feedback while patients gain timely access to safe and effective medical devices.”
In February 2025, the Trump administration fired FDA employees reviewing medical devices. One month later, Kennedy cut 3,500 FDA employees, but the agency said this mass layoff didn’t affect drug, medical device or food reviewers and inspectors. At the time, former FDA Commissioner Dr. Robert Califf said, “The FDA as we’ve known it is finished.”
The FDA said in June 2026 that it’s looking to hire 2,200 employees.
