Paris-based AI developer BrightHeart has received the CE mark for its B-Right prenatal ultrasound platform.
B-Right offers two capabilities: live acquisition guidance to support sonographers during scanning, and morphological evaluation of fetal organs designed to deliver structured diagnostic analysis regardless of operator experience, the company said. In a validation study of 877 examinations published in Obstetrics & Gynecology, the software identified findings associated with severe defects with 98.7% sensitivity and 97.7% specificity among conclusive exams, according to BrightHeart.
The CE mark follows an €11 million series A funding round, U.S. Food and Drug Administration clearances, and the platform's launch through GE HealthCare's Voluson Solution Store, the company noted.
