Summary: Sonio has received U.S. FDA clearance for the second version of their AI product, Sonio Detect, which improves ultrasound exams by automatically detecting views and anatomical structures with high sensitivity and specificity, streamlining workflows, and enhancing efficiency for healthcare professionals.

Key Takeaways

  1. Sonio Detect’s updated version has received U.S. FDA clearance and can automatically detect fetal ultrasound views and anatomical structures with high sensitivity and specificity.
  2. The system saves up to 10 minutes on complex exams by automatically extracting complex views and covers a significant portion of detailed exam protocols, with a goal to reach 100% coverage in the next release.
  3. Sonio’s AI and IT infrastructure streamline workflows, ensure HIPAA compliance, and enable secure remote review of images and reports for timely consultations.


Sonio has received U.S. FDA clearance for the second version of their AI product, Sonio Detect. This updated version automatically detects views and anatomical structures, facilitating high-quality ultrasound exams.

Key Product Capabilities

The new capabilities of Sonio Detect include recognizing fetal ultrasound views with 91.4% sensitivity for T1 views and 93.7% sensitivity for T2/T3 views. It also enables the automatic extraction of complex views, such as the heart and brain, from clips, saving up to 10 minutes on complex exams. The system can cover 60% of the International Society of Ultrasound in Obstetrics and Gynecology and 63% of American Institute of Ultrasound in Medicine detailed exam protocols without manual annotation, with a goal to reach 100% in the next release.

Additionally, Sonio Detect exhibits 93.4% sensitivity and 94.9% specificity for brain structures, and 91.9% sensitivity and 97.6% specificity for heart and thorax structures in the second and third trimesters. The system also detects structures of the placenta and crown-rump length/nuchal translucency, identifies placenta location, and determines fetal sex.

Increasing Efficiencies for Medical Teams

Sonio combines IT infrastructure and AI to streamline workflows and increase efficiency for healthcare professionals. It adheres to HIPAA compliance and encryption protocols to safeguard sensitive medical information and reduce the risk of data breaches.

Moreover, Sonio enables OB/GYN professionals to securely review images and reports remotely, allowing for timely consultations and second opinions. The Sonio Cloud reporting software is continuously updated to incorporate advancements in imaging technology, AI algorithms, and clinical decision support systems.

“We’re excited to reach this new milestone in Sonio’s launch in the U.S. market,” says Cecile Brosset, CEO of Sonio. “We are proud to continue expanding within the US provider market with this additional clearance.”