Koios Medical Gets Expanded Clearance for Ultrasound Cancer Software

Koios Medical has received the FDA’s expanded 510(k) clearance for its Koios DS, an artificial intelligence-based software platform for diagnosis of thyroid and breast cancer.

Koios DS Breast has already been commercially available in the U.S. since 2018. The expanded clearance is for detection of thyroid cancer.

The software, which draws upon ultrasound data from a network of 48 international sites, can help physicians interpret ultrasound scans, avoiding false-positives and unnecessary surgical procedures, the company said.