Sonio Receives FDA 510(k) Clearance for Sonio Detect

Sonio gets FDA(510K) Clearance

We are thrilled to share that our revolutionary AI-powered solution, Sonio Detect, has received FDA 510(k) clearance. 

Sonio Detect is a Software as a Service SaaS solution. It aims at helping sonographers, OB/GYNs,  MFMs, and Fetal surgeons to perform their routine fetal ultrasound examinations in real-time. Sonio Detect leverages deep learning networks to assist ultrasound practitioners in ensuring better Quality, Efficiency, and Expertise throughout the entire exam in real time by automatically:

  • Detecting and labeling views
  • Detecting anatomical structures within supported views
  • Verifying quality criteria of the supported views by checking whether they conform to standardized criteria

Sonio Detect is one of the very few AI solutions for OBGYNs, MFMs, Sonographers & Clinical Experts that can integrate with various ultrasound manufacturers. It is verified to have high sensitivity and specificity and maintain this high accuracy across various subgroups of patients (including BMI, maternal age, and ethnicity). 

The FDA’s recognition represents a groundbreaking milestone in our mission to revolutionize maternal care on a global scale. 

Cécile Brosset - Sonio

“This achievement is a result of our team’s hard work and determination. I want to express my gratitude to Florian Akpakpa, our head of regulatory affairs, for leading this effort till the end, and to the entire team for their incredible dedication. This accomplishment also reaffirms our commitment to give access to high-quality prenatal care to people all around the world.”

Cécile Brosset,
CEO Sonio

As we move forward, fueled by this remarkable achievement, we remain committed to pushing the boundaries of medical technology.

Rémi Besson

“This milestone marks just the beginning of an exciting journey. Sonio Detect’s FDA clearance propels us into a future where technology and medicine converge to reshape healthcare. The possibilities are limitless, and this achievement reinforces our dedication to the path ahead.”

Rémi Besson,
Chief Scientific Officer, Sonio

Our AI-augmented ultrasounds offer a comprehensive window into the health and development of their unborn child. This technology-driven experience provides a deeper connection and understanding, alleviating anxieties and offering a clearer picture of the journey ahead. With the FDA’s stamp of clearance, we’re not only advancing maternal care but also marking the beginning of a transformative journey in the USA.

Meet Sonio

Get a first overview on how the Sonio Platform will transform prenatal ultrasound examinations. Sonio Detect AI included.