Paris-based AI developer Sonio has received regulatory approval from the U.S. Food and Drug Administration for the use of Sonio Detect software in prenatal ultrasound examinations.
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 that after the Food and Drug Administration clearance and its recent $14 million (12.7 million euros) funding round, it is now ready to expand into the U.S. market.
