By Healthcare Brew Staff
less than 3 min read
Definition:
Breakthrough devices are medical devices the FDA believes could help treat serious or potentially fatal conditions. They are put on a fast track to be developed, reviewed, and ultimately approved by the agency.
How does a medical device qualify for breakthrough status?
According to the FDA, a device must be able to more effectively treat a life-threatening disease or condition and also meet the following criteria:
- It must be representative of a breakthrough technology, which in the past has included developments like artificial intelligence, deep brain stimulation, and CRISPR.
- There are no currently approved or cleared devices that treat the condition in a similar way.
- If there are other approved or cleared options, this new device shows a clear advantage.
- It would be in the best interest of patients if the device was more quickly available.
Since the program’s creation in 2015 and through 2023, 95 of the 933 devices given breakthrough device designation received FDA approval.
Where does CMS factor in to breakthrough device designation?
The Centers for Medicare and Medicaid Services (CMS) published a notice in August 2024 saying it would cut down the long wait times for these medical devices to receive Medicare coverage.
Previously, patients and manufacturers alike were held up by CMS’s national coverage determination (NCD), which decides how much Medicare will cover and can take up to five years. Under the newer Transitional Coverage for Emerging Technologies (TCET) Pathway, CMS hopes to make these NCD decisions within six months of a device receiving FDA approval. It also plans to review up to five devices per year.
