Sonio Receives FDA 510(k) Clearance* For Its Use of AI in Prenatal Ultrasounds
Femtech company becomes first fetal ultrasound startup using artificial intelligence to receive FDA clearance
Sonio, the artificial intelligence company revolutionizing fetal ultrasounds, announced today that their proprietary approach to ultrasound exams on pregnant people has now been recognized in the United States as a product that meets health performance and safety standards. Sonio has received Regulatory Class II FDA clearance for Sonio Detect, a product that uses AI to ensure high-quality exams, automatically detecting views and quality criteria of ultrasound images.
"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," says Sonio’s CEO and co-founder, Cecile Brosset.
Sonio Detect enables healthcare professionals to raise the bar on quality control of ultrasound exams whilst ensuring improved efficiency overall. In real-time, it automatically detects views, and anatomical structures within supported views, and verifies quality criteria of the supported views. With the use of the solution, healthcare professionals can quickly and efficiently detect the presence of heart and brain structures, and other important fetal imaging quality criteria.
After their most recent $14 million dollar funding round, and now FDA clearance, Sonio is ready to expand into the US market, with the goal of spreading high-quality, accessible maternal care across the globe. Sonio has made a commitment to bring the best of technology and clinical expertise to the service of medical performance and access.
"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,” says Remi Besson, co-founder of Sonio.
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 is able to accurately assist and automatically ensure protocols are properly completed based on images acquired by ultrasound technicians.
*FDA 510(k) clearance under K230365
About Sonio:
Sonio is an Artificial Intelligence solution for prenatal screening and diagnosis with over five years of research and collaborations between leading experts in fetal medicine and artificial intelligence. Sonio’s goal is to support fetal ultrasound practitioners in prenatal screening and diagnosis by assuring the completeness of their examination and increasing the accuracy of their patient scan results.
To learn more about Sonio, visit their website.