Koios Medical has received breakthrough device designation from the U.S. Food and Drug Administration (FDA) for its artificial intelligence (AI)-based software for the detection and diagnosis of breast and thyroid cancer.
Koios Decision Support improves breast and thyroid cancer detection rates and reduces unnecessary biopsies, the company said.
The FDA's breakthrough device program is a new coverage pathway under the Medicare Coverage for Innovative Technology program, which allows for national Medicare coverage as soon as the same day as FDA clearance for breakthrough devices, Koios said.
