French Startup Awarded FDA Clearance for AI-Driven Prenatal Ultrasounds –

French Startup Awarded FDA Clearance for AI-Driven Prenatal Ultrasounds –
French Startup Awarded FDA Clearance for AI-Driven Prenatal Ultrasounds –


What You Should Know:

  • 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.

 Regulatory Class II FDA Clearance for Sonia Detect Set to Revolutionize Pregnancy Care

“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, anatomical structures within supported views, and verifies quality criteria of the supported views. With use of the solution, healthcare professionals can quickly and efficiently detect 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 at 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, 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 complete based on images acquired by ultrasound technicians. 



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