In the final weeks of September, device makers announced a wave of FDA breakthrough designations for products ranging from abdominal CT triage algorithms to thrombectomy robots. These announcements came just before an October cutoff, after which new breakthrough-designated devices will no longer receive special Medicare payment treatment.
The Centers for Medicare and Medicaid Services finalized the change in August, eliminating pathways that since 2020 had let breakthrough devices qualify for new technology add-on payments and transitional pass-through payments without proving they were new or substantially better than existing alternatives. Starting next month, manufacturers seeking those extra payments will need to demonstrate substantial clinical improvement.
STAT's Breakthrough Device Tracker, which has catalogued nearly 800 devices since 2022, shows more than a dozen recent additions affected by the policy shift. The change applies only to devices receiving breakthrough designation after the deadline, meaning previously designated devices retain their existing eligibility.