Artificial intelligence (AI) software developer Us2.ai has secured U.S. Food and Drug Administration (FDA) clearance for its Us2.v1 echocardiography image analysis software.
Designed to serve as a decision-support tool for cardiologists and primary care physicians, the software application analyzes both 2D and cardiac Doppler ultrasound images and automatically measures 23 echocardiography parameters, according to the vendor. It then creates a fully automated patient report with editable annotations, conclusions, and comparisons with international reference guidelines, the company said.
The software's performance has been assessed in an external validation study performed at Brigham and Women's Hospital. It's now available in the U.S.