Sonio – an AI company revolutionizing fetal ultrasounds – recently announced that their proprietary approach to ultrasound exams on pregnant people has been recognized in the United States as a product that meets health performance and safety standards. And Sonio has received Regulatory Class II FDA clearance for Sonio Detect. This product uses AI to ensure high-quality exams, automatically detecting views and quality criteria of ultrasound images.
Sonio Detect enables healthcare professionals to raise the bar on quality control of ultrasound exams while ensuring improved efficiency. In real-time, it automatically detects views and anatomical structures within supported views and verifies the quality criteria of the supported views. With the solution, healthcare professionals can quickly and efficiently detect the presence of heart and brain structures and other crucial fetal imaging quality criteria.
After their most recent $14 million funding round and now FDA clearance, Sonio is ready to expand into the US market to spread high-quality, accessible maternal care across the globe. Sonio has committed to bringing the best of technology and clinical expertise to the service of medical performance and access.
Sonio Detect’s software was found to have a high accuracy rate in identifying correct labels, views, and quality criteria, regardless of manufacturers, patients’ BMI, age, ethnicity, and gestational age. Additionally, Sonio Detect proved its performance validating it on over 17k ultrasound images, with more than 92% sensitivity on its ability to detect labels and types of Ultrasound images, for instance. This means that Sonio can accurately assist and automatically ensure protocols are properly completed based on images acquired by ultrasound technicians.
KEY QUOTES:
“Bringing the first easy-to-use, manufacturer-agnostic (GE, Samsung, and Canon) and efficient quality control solution to all OBGYNs, MFMs, and Sonographers, we believe better screening will lead to better detection of potential anomalies or reassurance to provide better maternal care. Our goal is to transform prenatal care by providing a reliable tool that ensures better health outcomes for both mothers and babies.”
— Sonio’s CEO and co-founder, Cecile Brosset
“We are deeply committed to advancing the field of prenatal health through innovation at Sonio. Obtaining FDA clearance for our products demonstrates our dedication to safety and efficacy in the US market. Our goal is to ensure everyone has access to top-quality prenatal care across the globe.”
— Remi Besson, co-founder of Sonio
