The U.S. Food and Drug Administration (FDA) has cleared Paris-based AI developer Sonio's Sonio Detect for prenatal ultrasound exams.
Sonio Detect can detect views and anatomical structures, as well as verify quality criteria in real-time, the company said. This allows users to identify the presence of heart and brain structures.
Sonio Detect's software can identify labels, views, and quality criteria regardless of manufacturers, body mass index of patients, age, ethnicity, and gestational age, according to the firm. The technology achieved a sensitivity of 92% when detecting labels and types of ultrasound images in a validation study of about 17,000 images, Sonio added.
Sonio said with the FDA clearance and its recent $14 million funding round, it is ready to expand into the U.S. market.
